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Making a paradigm shift

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					                                                      Special Programme for Research & Training
                                                      in Tropical Diseases (TDR) sponsored by
                                                      U N I C E F / U N D P / W o r l d B a n k / W H O




                                                                                  No. 82 - M a r c h      2009




                              Making a paradigm shift
                 The Bamako 2008 Global Ministerial Forum on Research for Health | PAGE 12


                                      29	 •		Empowerment	SAC	
Also in this issue                        •		ANDI	Task	Force
                                                                                               PAGE
                                      30	 • Chagas	disease	protocol
4 Research briefs                                                                                  19
                                      	 • ASTMH	and	rectal	artesunate
7 TDR briefly                         32	 • DEEP	on	ineffective	diagnostics      Liberia diary:
24 HAT research in Uganda             	 •	 Biosafety	courses	launched	              ‘greening’
                                          	 in	Mali
MEETinGs                                                                      clinical trials in
27	 •		Stewardship	SAC                33	 • Sudan	adopts	HMM	strategy
                                                                                a remote site
    •		Environment,	agriculture	and   34 Publications
    	 infectious	diseases	            36 Grants
                           Letter from the editor




                           Powering sustainable research



                           I
         page     9                           n	TDR	we	speak	a	great	deal	about	
                                             using	the	research	that	we	do	in	
                                                                                        Solar	power	generation	capacity	not	only	would	as-
                                                                                        sure	the	sustainability	of	the	infrastructure	invest-
                                           countries	not	only	for	a	particular	drug	    ment	in	Bolahun	for	other	trials	for	neglected	tropi-
                                         trial	or	project,	but	also	to	build	more	      cal	diseases,	but	it	could	potentially	power	existing	
                                      “sustainable”	research	and	health	services	       facilities	of	a	nearby	health	centre,	and	also	Bolahun	
                                   capacity	in	poorly	resourced	locales.	               High	School.	

                              Now,	a	drug	trial	of	moxidectin,	a	potential	drug	        The	high	school,	founded	by	monks	in	1925 and	a	
                           for	the	eradication	of	onchocerciasis	in	Africa,	to	be	      focus	of	Peace	Corps	volunteer	activity	in	the	1960s	
                           conducted	in	Liberia	and	the	Democratic	Republic	of	         and	1970s,	has	an	interesting	history.	It	had	a	national	
                           Congo,	is	adding	another	dimension	to	the	quest	for	         reputation	for	academic	excellence	before	the	war,	

       page    19          sustainability	–	an	environmental	dimension.	

                           The	clinical	trial	site	in	Bolahun,	Liberia,	in	a	remote	
                                                                                        and	has	recently	been	rebuilt	thanks	to	the	support	
                                                                                        of	a	network	of	distinguished	alumni.	

                           northern	border	region	that	was	once	the	scene	of	           Kuesel	recruited	a	master’s	degree	student	to	make	
                           civil	war,	offers	the	most	dramatic	example	of	the	          detailed	engineering	plans	for	a	photo-voltaic	system	
                           challenges	involved	(see	page	19).	                          sufficient	to	fuel	the	research	and	health	centre	
                                                                                        and	the	school.	Unfortunately,	a	donor	has	yet	to	be	
                           The	trial	site	development	in	Bolahun	has	involved	
                                                                                        found.	
                           the	construction	of	a	major	new	research	centre	that	
                           will	house	the	Phase	III	clinical	trial	activities.	Capac-   The	fact	that	the	sturdy,	modern	centre	was	built	
                           ity	development	at	the	Liberia	trial	site,	as	well	as	       with	sun-dried	mud	bricks	and	that	other	“green”	
                           those	in	DRC,	has	largely	been	funded	through	a	             measures	have	been	considered,	such	as	solar-

      page     24          US$	6	million	donation	from	Wyeth	Pharmaceuticals,	
                           owner	of	the	moxidectin	compound.	
                                                                                        powered	health	waste	disposal	and	re-use	of	biofuel	
                                                                                        waste	from	nearby	banana	and	rice	fields,	make	the	
                                                                                        Bolahun	story	a	potential	case	study	of	efforts	to	
                           However,	despite	the	generous	donation,	guarantee-
                                                                                        “green”	health	research	facilities	in	remote	locales.	
                           ing	a	power	supply	to	the	site	has	been	an	ongoing	
                           challenge.	                                                  Charged	by	our	Joint	Coordinating	Board	to	address	
                                                                                        climate	change	impacts	and	issues	on	neglected	
                           The	centre,	soon	to	begin	recruiting	patients,	cur-
                                                                                        diseases,	we	find	the	Bolahun	story	one	of	the	most	
                           rently	is	powered	by	diesel	fuel.		However,	diesel	
                                                                                        palpable	examples	of	how	TDR	can	be	a	leader	of	
                           power	capacity	could	be	unpredictable,	due	to	the	
Communications                                                                          innovation	in	the	research	sector.	Learning	from	the	
Manager                    site’s	remote	location,	(a	10-hour	trip	from	Monrovia,	
                                                                                        Liberian	experience,	we	can	explore	how	to	incorpo-
Jamie Guth                 partly	over	dirt	roads	in	dry	weather).	Even	though	a	
                                                                                        rate	environmental	and	climate	change	mitigation	
Managing Editor            backup	generator	has	been	installed,	any	interrup-
                                                                                        features	into	our	field	and	clinical	research	activities	
Elaine Fletcher            tion	in	fuel	supply	or	failure	of	one	of	the	generators	
                                                                                        –	supporting	the	global	drive	for	sustainable	develop-
Design and Layout          could	threaten	the	successful	collection	of	data	es-
Lisa Schwarb
                                                                                        ment	through	our	research	work.	
                           sential	to	the	trial.	
Production Team                                                                         But	becoming	a	model	requires	us	to	first	complete	
                           Also,	once	the	trial	is	completed	in	three	years’	time,	
Jocelyne Bruyère                                                                        our	work	in	Bolahun.	And	that	means	locating	donors	
Pelthia Makgatho           there	is	no	guaranteed	budget	for	supply	of	fuel	to	
                                                                                        for	a	15KW	solar	power	generation	system.	
Patrick Adams              continue	powering	the	array	of	laboratory,	clinical,	
(reporter)                 ophthalmological	and	computer	equipment,	which	              Any	takers,	please	tell	us…
Ali Bhanpuri
(intern)                   could	be	used	for	further	research	or	in	the	delivery	
                           of	more	routine	health	services.	
Cover photo:
The Bamako                 In	order	to	address	such	issues,	TDR’s	Annette	Kuesel,	
International Conference   who	is	coordinating	the	moxidectin	research	effort	
Centre in Mali, scene of
                           together	with	Fatorma	Bolay	of	the	Liberia	Institute	
the Global Ministerial
Forum on Research for      of	Biomedical	Research,	developed	a	plan	to	provide	         Elaine Ruth Fletcher
Health, 17-19 November     solar	power-based	electricity	to	the	centre.	                Managing Editor, TDRnews
2008, which drew
1100 participants from
around the world.
(Olivier Asselin)
Letter from TDR’s director                                                                                                                         No. 82




Optimizing global health
research ‘architecture’
Research	 policy	 actors	 are	 examining	 critical	 ques-                       cation	 in	 activities	 and	 administration	
tions	 about	 how	 the	 global	 community	 can	 act	 on	                        needs	 to	 be	 examined.	 Just	 as	 donors	
recent	calls	for	massive	new	investment	into	a	global	                          are	urged	to	“harmonize”	activities,	we	   	
R&D	effort	targeting	neglected	diseases.                                        need	to	examine	ourselves	and	see	how	
                                                                                we	are	collaborating	with	our	partners.	
The Global Strategy and Plan of Action on Public Health,                        However,	 any	 proposed	 reorganization	
Innovation and Intellectual Property	(GSPA),	approved	                          must	consider	that	the	ultimate	goal	is	
by	 the	World	 Health	 Assembly	 in	 May	 2008,	 has	 led	                      to	improve	efficiency,	responsiveness	to	
to	the	creation	of	a	major	WHO	task	force	on	sustain-                           scientific	opportunity	and	the	needs	of	
able	financing	of	research.	This	highlights	the	need	to	                        developing	 countries	 –	 and	 not	 merely	
spend	much	more	on	such	research.	                                              superimpose	 another	 layer	 of	 bureau-
                                                                                cracy.	
Right	now,	only	3%	of	the	US$	160	billion	spent	glob-
ally	 on	 health	 research	 is	 invested	 in	 neglected	 dis-                   TDR	 is	 in	 a	 pivotal	 position	 in	 this	 de-
eases.	Some	argue	this	should	quadruple	to	12%	over	                            bate.	 TDR’s	 special	 programme	 model	
the	next	six	years.                                                             of	 governance	 equally	 involves	 both	
                                                                                developed	and	developing	country	gov-
If	funds	of	such	an	order	of	magnitude	are	to	be	lever-
aged	then	investors,	whether	private	or	public	donors,	
                                                                                ernments.	As	TDR’s	Joint	Coordinating	
                                                                                Board	chairman	has	remarked,	the	co-sponsorship	of	
                                                                                                                                                   3
need	 to	 be	 assured	 that	 the	 international	 organiza-
                                                                                TDR	by	several	UN	agencies	makes	the	Programme	re-
tions	and	NGOs	engaged	in	research	have	coordinat-
                                                                                sponsive	not	to	only	WHO,	but	to	the	UN	system	more	
ed	 mandates	 for	 action	 that	 optimize	 their	 efficient	
                                                                                broadly.	We	believe	that	the	maintenance	of	this	gov-
use	 of	 funds	 and	 can	 appropriately	 support	 regional	
                                                                                ernance	model	is	crucial	if	developing	countries	are	to	
and	national	efforts.
                                                                                play	 a	 pivotal	 role	 in	 global	 research	 for	 health,	 and	
WHO-associated	and	other	health	research	agencies	                              if	 research	 is	 to	 remain	 accountable	 to	 high	 disease	
have	thus	been	called	upon	to	improve	coherence	of	                             burden	countries.
programmes,	or	even	consider	a	merger	of	certain	in-
                                                                                There	 will	 be	 furthered	 discussion	 of	 TDR’s	 position	
ternational	research	efforts.1
                                                                                and	 role	 in	 research	 coordination	 and	 alignment	 at	
This	 need	 to	 review	 global	 health	 ‘architecture’	 was	                    the	next	Joint	Coordinating	Board	session,	15-17	June.	
noted	in	the	Bamako call for action	at	the	close	of	the	                        It	is	important	to	bear	in	mind	the	good	news	inher-
Global	 Ministerial	 Forum	 on	 Research	 for	 Health	 in	                      ent	to	this	debate:	that	is	the	wave	of	interest	in	re-
November	2008.                                                                  search	for	health,	both	at	the	global	policy	level	and	
                                                                                from	 developing	 countries.	 At	 the	 Bamako	 Forum,	
In	direct	response	to	the	Bamako	call,	WHO’s	Execu-                             I	spoke	with	the	minister	of	health	from	Sierra	Leone,	
tive	Board,	meeting	in	January,	asked		actors	to	“better	                       a	country	recovering	from	civil	war.	He	was	adamant	
align	and	coordinate	the	global	health	research	archi-                          that	development	of	research	capacity	was	critical	to	
tecture	 and	 its	 governance	 through	 the	 rationaliza-                       health	and	development.
tion	 of	 existing	 global	 health	 research	 partnerships,	
to	improve	coherence	and	impact,	and	to	increase	ef-                            TDR	 is	 building	 such	 capacity	 on	 the	 ground.	 In	 this	
ficiencies	and	equity.”	2                                                       TDRnews	issue,	we	feature	efforts	in	Liberia	and	Ugan-
                                                                                da,	where	research	investments	are	greeted	with	en-
The	 matter	 is	 sure	 to	 also	 arise	 as	 the	World	 Health	                  thusiasm	 and	 involvement	 by	 policy	 leaders	 as	 well	
Assembly	considers	approval	of	a	new	WHO	research	                              as	 local	 communities.	 Engaging	 and	 responding	 to	
strategy	in	May.	No	single	programme	or	agency	can	                             country	 needs	 has	 to	 be	 kept	 in	 the	 forefront	 of	 our	
remain	 aloof	 to	 the	 questions	 being	 asked	 and	 the	                      thinking.	It	is	these	efforts	that	will	lay	a	good	founda-
challenges	 posed.	There	 are	 indeed	 multiple	 inter-                         tion	for	a	research	‘architecture’	that	is	strong,	stable	
national	 research	 initiatives	 operating	 from	 WHO,	                         and	durable.
involving	 other	 partners.	 And	 there	 are	 multiple	
NGO	initiatives	promoting	research.	Potential	dupli-



1	 Røttingen	JA,	Marchiori	Buss	P,	Davies	S,	Touré	O.	Global-health	research	
   architecture—time	for	mergers?	The Lancet 373: 9659, pp 193-195
                                                                                Dr Robert Ridley
2	 WHO	Executive	Board	resolution:	EB124.R12	(http://www.who.int/gb/
   ebwha/pdf_files/EB124/B124_R12-en.pdf)                                       TDR Director
    No. 82




                                                          REsEaRCH briefs
                                                          •	 The Lancet – Rectal artesunate can save lives of severe malaria patients
                                                          •	 Gatifloxacin trial: Patient enrolment target is met
                                                          •	 New TDR study to evaluate if home management reduces malaria mortality
                                                          •	 Glossina genome is 80% sequenced – completion planned in 2009
                                                          •	 Phase 2 of eco-bio-social research launched
                                                          •	 WHO/TDR establish Pregnancy Register




                              malaria                                          new tb treatment                                 Because gatifloxacin has been associated
                                                                                                                                with the problem of hypo- and
                              The Lancet – Rectal                              Drug trial meets patient                         hyperglycaemia, patients with a history of
                              artesunate can save lives                        enrolment target                                 diabetes or abnormal blood glucose levels
                              of severe malaria patients                       A pivotal Phase III trial of a shorter,          have been excluded from the trial. It is
                              “A rectal application of the                     4-month course for tuberculosis (TB)             expected that the initial analysis of safety
                                                                               treatment has taken a significant step           and efficacy will be conducted 1 year
                              inexpensive antimalarial drug
                                                                               forward after the enrolment quota of
4
                                                                                                                                post-treatment, i.e. in mid-2010, followed
                              artesunate could save the lives of               1836 volunteer patients was reached at           by a final 2-year analysis. Should the
                              many people who develop severe                   African study sites. The trial is testing        initial 1-year analysis be positive, it
                              malaria who live in the world’s                  a 4-month course of TB multidrug                 is anticipated that a formal file for
                              remotest locations, e.g. rural Africa            treatment including gatifloxacin against         registration of a gatifloxacin-containing
                              and Asia.”                                       the standard 6-month multidrug TB                TB drug combination will be submitted to
                                                                               course.                                          the United States of America’s Food and
                                                                               The trial, launched in 2005, aims to assess      Drug Administration and other regulatory
             WHO/TDR/Craggs




                                                                               whether the new regimen is safe and as           authorities in late 2010 or early 2011.
                                                                               effective as the standard 6-month regimen.       >> For complete report, see:
                                                                               The achievement of the target sample             http://www.who.int/tdr/svc/news-events/
                                                                               size in October 2008 means that the final        news/shorter-tb-drug-trial
                                                                               patients needed for the study will now
                                                                               complete treatment in the second quarter
                                                                                                                                   For more inFo
                                                                               of 2009.
                                                                                                                                   Dr Piero Olliaro:
                                                                               TB centres of the national TB control               olliarop@who.int
                                                                               programmes in Senegal and Benin together
                                                                               with clinical and research institutions
                                                                               in Guinea, Kenya and South Africa are
                                                                               partners in the study, which is being
                                                                               conducted in collaboration with the
                                                                                                                                tDr evaluation
                                                                               European Commission (EC)-funded
                                                                               Oflotub Consortium. TDR provides
                                                                                                                                Does HMM reduce malaria
                                                                                                                                mortality?
                                                                               co-sponsorship and funding, as well
                                                                               as technical oversight in collaboration
                                                                               with the Institut de Recherche pour le           TDR is to evaluate whether distribution
                                                                               Développement (IRD), France.                     of free artemisinin-combination therapies
                                                                                                                                (ACTs) through home-based management
                                                                               In 2003, TDR and the Oflotub Consortium
                                                                                                                                of malaria (HMM) can reduce malaria
                              These are the conclusions of a TDR-              began a programme to develop and register
                                                                                                                                mortality as well as morbidity.
                              supported study published recently in            a TB treatment containing gatifloxacin,
                              The Lancet, “Pre-referral rectal artesunate      an oral fluoroquinolone antibiotic               The TDR research will be carried out in
                              to prevent death and disability in severe        with activity against Mycobacterium              the context of a major US$ 20 million
                              malaria: a placebo-controlled trial.”            tuberculosis. In the Phase III trial involving   initiative to extend HMM, including
                              The research was presented at the                adults under the age of 65, patients are         ACTs offered free-of-charge, to some
                              December 2008 meeting of the American            randomly allocated to receive either the         10 million Africans in four countries. The
                              Society of Tropical Medicine and Hygiene         standard 6-month TB treatment or the             initiative was launched 16 February in
                                                                               shortened tested treatment (rifampicin +         Nairobi, by the Canadian International
                              (for more details see page 30).
                                                                               isoniazid + pyrazinamide + gatifloxacin          Development Agency (CIDA) and
                                                                               for 2 months, followed by rifampicin +           Population Studies International (PSI), a
                                                                               isoniazid + gatifloxacin for 2 months).          Washington, DC-based NGO.
                                                                                                                                                                                        No. 82
                                                                                                                                                                                        No. 82




                                                                   Glossina genome                                                disease-endemic countries (DECs) to
WHO/TDR/Pagnoni




                                                                                                                                  exploit the data to develop new vector
                                                                   sequencing at 80% mark –                                       control strategies. TDR aims to facilitate
                                                                   completion planned in 2009                                     DEC involvement in genomics research
                                                                                                                                  through seed-funding of preparatory
                                                                   Researchers at the Wellcome Trust                              activities and support for regional training
                                                                   Sanger Institute have sequenced 80% of                         centers that would offer courses in
                                                                   the Glossina m. morsitans, the tsetse fly                      bioinformatics and functional genomics.
                                                                   species that is a vector of human African
                                                                   trypanosomiasis (HAT), in the context of                                                                         	
                                                                                                                                      For more inFo
                                                                   a TDR-supported international genomics
                                                                   effort.                                                            Dr Yeya Touré:
                                                                                                                                      tourey@who.int
                  Over the next 2-3 years, the TDR
                                                                   The International Glossina Genomics
                  scientists will monitor the impact of the
                                                                   Initiative (IGGI) has now drawn up
                  home-based effort on ACT treatment to
                                                                   an implementation plan for complete
                  determine if indeed it reduces mortality
                                                                   sequencing of the Glossina genome                              eco-bio-social research
                  from malaria.
                                                                   by 2009, with sequence assembly to
                  What makes the TDR research ground-              follow this year as well. The plans were                       six countries test dengue
                  breaking is that the effectiveness of the        discussed at IGGI’s sixth annual meeting                       interventions
                  home-based approach for delivering ACTs          in Mombasa, Kenya, during November
                                                                                                                                  A multi-country research effort in Asia
                  on child mortality has never before been         2008.
                                                                                                                                  designed to study dengue transmission
                  monitored. ACTs also are not yet widely                                                                         and then test social and ecosystem-based
                  available in Africa, particularly for the        IGGI members have proposed that
                                                                                                                                  interventions is launching its Phase II.
                  most poor and vulnerable people.                 completion of the sequencing can be

                                                                                                                                                                                        5
                                                                                                                                  Following the completion of the Phase I
                                                                   expedited by using a new sequencing
                  Research has, however, demonstrated                                                                             situation analysis, all six sites will initiate
                                                                   technology that is more efficient and
                  that prompt and effective treatment of                                                                          tests of various community-based
                                                                   less expensive than conventional means,
                  uncomplicated malaria (usually with                                                                             management approaches in April. These
                                                                   providing the estimated US$ 250 000 in
                  chloroquine) prevents an infection’s                                                                            are designed to address locally identified
                                                                   funding needed for the effort is secured.
                  evolution to severe malaria and death.                                                                          factors in disease transmission.
                                                                   The new 454 FLX sequencing technology
                                                                   was recently developed by Roche                                The initiative, funded by the EcoHealth
                  If the health impact of delivering
                                                                   Diagnostics. IGGI is an international                          Programme of the Canadian International
                  ACTs (free-of-charge) through HMM
                                                                   consortium that was convened by TDR                            Development Research Centre (IDRC),
                  is significant, results would serve as a
                                                                   in 2004 to accelerate genomics-based                           involves multi-disciplinary research
                  powerful catalyst for the expansion of
                                                                   research on the Glossina genome.                               teams at universities and research centres
                  such programs across sub-Saharan Africa.
                                                                                                                                  in India, Indonesia, Myanmar, the
                  The CIDA/PSI project will cover some             HAT is estimated to infect about 300 000                       Philippines, Sri Lanka and Thailand.
                  2.5 million people in each participating         people worldwide, with an additional
                                                                                                                                  The initiative has been designed to
                  country. Community selection will be             60 million people in 37 African countries
                                                                                                                                  improve dengue prevention through better
                  based on criteria such as high malaria           considered to be at risk. The same species
                                                                                                                                  understanding of its ecological, biological
                  burden and the existence of community-           of tsetse fly also is a carrier of animal
                                                                                                                                  and social (“eco-bio-social”) determinants.
                  based health networks. TDR will evaluate         African trypanosomiasis (AAT), whose
                  impacts of the programme in a subset of          effects on agriculture have hindered                           Eco-bio-social research is a trans-
                  the trial population in three countries.         economic development in rural areas                            disciplinary research concept that
                  TDR scientist Franco Pagnoni, overseeing         and cost African farmers almost US$ 4.5                        integrates research on environmental,
                  the evaluation, estimates that the project       billion every year.                                            vector-epidemiological (entomological)
                  could potentially avert up to 11 000 child                                                                      and social factors that make communities
                                                                   According to Yeya Touré, TDR’s                                 vulnerable to vector borne diseases such
                  deaths in each of the four pilot areas.
                                                                   innovative vector control interventions                        as dengue. The aim of such research is
                  HMM provides a regimen of pre-                   leader, a fully sequenced genome would                         to develop inter-sectoral approaches to
                  packaged, unit-dosed antimalarials along         represent a significant contribution to                        disease control, addressing issues that
                  with associated health communication             current and future vector control efforts.                     extend beyond traditional boundaries of
                  materials.	WHO has adopted HMM as                This would happen in part by helping                           health-sector activities.
                  a cornerstone of disease-control efforts,
                                                                                                                WHO/TDR/Fischer




                  particularly in Africa, where half or more                                                                      In the current study, research teams
                  of all malaria cases are treated at home.                                                                       are examining both effectiveness and
                                                                                                                                  community acceptance of locally developed
                  Yet there remains “inadequate access                                                                            vector control measures. For instance, in
                  to ACTs for such treatment,” according                                                                          Yangon, Myanmar, teams will examine
                  to the 2008 World Malaria Report.                                                                               how use of natural predators and biological
                                                               	                                                                  larvicides such as dragonfly nymphs and
                     For more inFo                                                                                                Bacillus thuringiensis serovar israelensis
                                                                                                                                  (Bti), as well as water covers, window
                     Dr Franco Pagnoni:
                                                                                                                                  curtains and waste control measures,
                     pagnonif@who.int
                                                                                                                                  may reduce vector densities. Stakeholder
    No. 82



                                                                                            Drug safety                                    healthy pregnancies and their outcomes,


             WHO/TDR/Craggs
                                                                                                                                           along with data on pregnant women
                                                                                            WHO/TDR establish                              exposed to drug treatment,” Islam said.
                                                                                            Pregnancy Register                             “The women not exposed to the drug of
                                                                                            A new Global Pregnancy Register to             interest will act as controls, as it were, in
                                                                                            collect epidemiological data on the            comparison to women exposed to drugs
                                                                                            impacts of new drugs for malaria, HIV          of interest, enabling identification of any
                                                                                            and other major diseases on pregnant           increased (or no increased) risk of birth
                                                                                            women is being established by the              defects due to a drug.”
                                                                                            Making Pregnancy Safer Programme of            The plans and funding for pilot testing of
                                                                                            WHO, TDR and several other WHO                 the register were approved at an informal
                                                                                            departments. The register will provide         consultation of the Malaria Pregnancy
                                                                                            the evidence on drug safety in pregnancy       Register Protocol in Geneva, 7-8 Novem-
                                                                                            from resource-poor settings of Africa,         ber 2008. This was a joint meeting
                                                                                            Asia and Latin America. The register           of TDR/MPS, the HIV Programme,
                                                                                            will enable assessment of the risks and        the Quality and Safety of Medicines
                              Thailand is one of many Southeast Asian                       benefits of new drugs for HIV, malaria,        Programme and the Global Malaria
                              countries implementing new dengue                             leishmaniasis and other neglected tropical
                              prevention projects.                                                                                         Programme of WHO.
                                                                                            diseases, whose safety and efficacy in
                                                                                            pregnant women have not been fully             Pilot testing of questionnaires and
                                                                                            established.                                   methods to be used in the register are
                              alliances, community partner groups
                                                                                                                                           being implemented in 2009 in targeted
                              and volunteers will be involved in these                      Data on outcomes of such drug use are          health clinics of at least five African
                              activities.                                                   very scanty because pregnant women             countries, prior to launching to scale.
                                                                                            typically are excluded from clinical trials    Development of systems for effective
                              In Muntinlupa City, Philippines, part
                                                                                            of new medications in order to protect         tracking of exposures to medicines,
                              of the metropolitan Manila region, the
                                                                                            them and their unborn children, says           and awareness of its importance, are
6
                              Phase II work also aims to evaluate
                                                                                            MO Islam, MPS director.                        particularly challenging in countries
                              relative acceptance by communities
                              and local governments of community-                           Thus for major and life-threatening            where capacity of antenatal care
                              based vector control efforts involving                        diseases such as HIV or malaria, pregnant      programmes to conduct such monitoring
                              solid waste management, lid covers for                        women are often treated with safe but          is currently weak.
                              key containers, larvicides and health                         potentially less efficacious medicines until   As part of the effort, WHO/TDR also are
                              education measures. The social research                       cumulative evidence is gathered on the         issuing calls to researchers worldwide
                              element will include stakeholder                              safety of newer first-line drugs, often over   for contributions of results from studies,
                              meetings, key informant interviews and                        many years.                                    reports and patient data sets on maternal
                              focus group discussions.                                                                                     outcomes and prevalence of birth defects
                                                                            WHO/TDR/Crump




                                                                                                                                           in Asia, Africa and Latin America. These
                              Similar projects are taking place in
                                                                                                                                           will be included in a planned WHO
                              Gampaha District, Sri Lanka; Chennai,
                                                                                                                                           systematic review of the issue (Please see
                              India; Yogyakarta, Indonesia; and
                                                                                                                                           Calls on TDRnews back page).
                              Chachoengsao Province, Thailand.
                              The project in Thailand aims to measure                                                                      >> See also TDR web link:
                              the efficiency of insecticide impregnated                                                                    safety of artemisinins in pregnancy
                              window curtains and water container                                                                          http://www.who.int/tdr/svc/research/
                              covers on the reduction of vector density                                                                    antimalarial-policy-access/projects#_
                              measured by standard entomological                                                                           Safety_of_the	
                              indices. EcoHealth volunteers and
                              students will be engaged in applying
                              the vector control methodologies at the                                                                         For more inFo
                              community level.                                                                                                Dr Melba Gomes:
                              “The aim is to show that dengue                                                                                 gomesm@who.int
                              transmission can be reduced with an
                              appropriate management of ecosystems,
                              in different ecological environments.”
                              said Dr Olaf Horstick, a TDR technical                  Yet de facto, many women become
                              officer involved in TDR’s eco-bio-social                pregnant while taking such drugs or
                              efforts. “If this concept is successful the             may be exposed before they or their
                              studies should underline the importance                 health care providers are aware of the
                              of inter- and intrasectoral approaches to               pregnancy. Better tracking of subsequent
                              the control of vector-borne, but also other             pregnancy outcomes in such women,
                              communicable diseases.”                                 and comparison with their unexposed
                                                                                      peers, can help establish the safety of new
                                                                                    	 drugs or identify potentially problematic
                                 For more inFo
                                                                                      consequences.
                                 Dr Johannes Sommerfeld:
                                 sommerfeldj@who.int                                        “The important thing about this register
                                                                                            is that it will collect data on unexposed
                                                                                                                                                                  No. 82
                                                                                                                                                                  No. 82



                                                                                        •	 STAC	commends	TDR	progress        •	 WHO	commends	Chinese	



                  TDRbriefly
                                                                                        •	 Global	spending	on	neglected	        LF	elimination
                                                                                           disease	research	                 •	 TDR	affiliate	is	Gambia	WR
                                                                                                                             •	 TDR	grantee	lauded	for	TB	
                                                                                        •	 ESSENCE	pilots	activities            research
                                                                                        •	 Good	clinical	laboratory	         •	 Top	Guatemalan	award	to	
                                                                                           practices                            TDR’s	Byron	Arana	




                  STAC commends TDR’s                                    as “significant”, and commended the           80% of neglected disease
                  strategy implementation                                work of the other lines of TDR activity       research spending is for
                                                                         as “satisfactory” to “excellent”. However     HIV, malaria and TB
                  TDR’s Scientific and Technical Advisory                it noted the need to develop clearer
                  Committee (STAC) met in Geneva                         strategies and indicators to ensure           Of the more than US$ 2.5 billion spent
                  on 23-26 February and commended                        that disease- endemic countries play          in 2007 on neglected disease R&D,
                  TDR for the good progress attained                     a pivotal role in global research, in TDR     almost 80% went to HIV/AIDS, malaria
                  over 2008. This was the first year of                  research in particular, and in setting        and tuberculosis (TB), a new report on
                  implementation of TDR’s new strategy,                  the health research agenda. STAC also         global investment in new products for
                                                                         asked TDR to develop longer term              neglected diseases says.
                  which aims to give disease endemic
                                                                         indicators of the impacts of various
                  countries a pivotal role in research that                                                            The remaining neglected diseases and
                                                                         TDR research activities on the success
                  addresses diseases of poverty.                                                                       disease groupings, including diarrhoeal
                                                                         of disease control efforts.
                                                                                                                       illnesses, helminth infections and
                  Under the new strategy, approved
                                                                                                                       bacterial pneumonia and meningitis,
                                                                                                                                                                  7
                                                                         “Issues that are now coming into
                  by TDR’s Joint Coordinating Board in
                                                                         focus include a need for TDR to not           each received less than 5% of global
                  2007, specific areas of TDR research
                                                                         only better describe what we do but           funding, according to the G-Finder
                  focus include the early stages of
                                                                         the processes we use, i.e. how we             report by the Australia-based George
                  “discovery” research for new drugs
                                                                         function,” said Director Robert Ridley,       Institute for International Health.
                  and diagnostics tools, as well as
                                                                         following the meeting. “There needs           In terms of the types of research
                  implementation research aiming to
                                                                         to be a particular emphasis on how            funded, the lion’s share of global
                  improve drug, diagnostics and health
                                                                         we are going to help disease-endemic          investment went to R&D of drugs and
                  service delivery in real-life settings. Two
                                                                         countries play a pivotal role for             vaccines, with very little dedicated
                  key crosscutting TDR functions include
                                                                         research. This means we will be looking       to diagnostics. Over 80% of global
                  “stewardship” of research priorities
                                                                         very closely in the coming year at how        funding was provided by only 12
                  aiming to identify research needs
                                                                         we measure and evaluate the impact            organizations. The report recommends
                  and gaps and improve knowledge
                                                                         of our work with developing countries,        broadening funding so that all
                  sharing, as well as “empowerment”
                                                                         and also how we walk the talk about           diseases receive the attention they
                  of research leadership in disease-
                                                                         disease endemic country leadership.” n        deserve and more funders become
                  endemic countries. The STAC termed
                                                                                                                       involved in such R&D efforts.
                  progress in TDR’s Stewardship function
                                                                                                                       The G-Finder report, supported by the
                                                                                                                       Bill and Melinda Gates Foundation,
WHO/TDR/Schwarb




                                                                                                                       surveyed 2007 R&D investments of
                                                                                                                       134 donors and private as well as public
                                                                                                                       programmes/agencies (including
                                                                                                                       TDR) in 43 countries. The report on
                                                                                                                       funding trends aims to identify areas
                                                                                                                       in which funding is lacking and where
                                                                                                                       additional funding can potentially
                                                                                                                       have a high impact.
                                                                                                                       Around 20% of global funding was
                                                                                                                       invested by public institutions and
                                                                                                                       private companies into internal
                                                                                                                       programmes, the report found. The
                                                                                                                       remaining 80% was granted to
                                                                                                                       external organizations either directly
                                                                                                                       or via “intermediary” organizations
                                                                                                                       such as TDR as well as product
                                                                                                                       development partnerships (PDPs).
                                                                                                                       Among the intermediary organizations,
                  The STAC board at the 31st session held in February.                                                 TDR ranks eighth in terms of funding.
    No. 82



             In making R&D investments, funders           Cooperation (NORAD), the Swedish                and adapt the guidelines as part of an
             need to assess the likely health return      International Development Cooperation           overall effort aiming to help disease
             against the cost of any investment,          Agency (Sida), the Bill and Melinda             endemic country laboratories meet
             discounted for risk, the report              Gates Foundation, and the Wellcome              international good practice standards.
             emphasized. This is a complex process        Trust.
             and factors include burden of disease,                                                       See web link to GCLP guidance in the
                                                          Subsequent to the pilot in Tanzania, the
                                                                                                          Publications section (page 34). n
             epidemiological trends, product              ESSENCE Steering Committee also met
             shortfalls and the presence of other         in concurrence with the Stakeholders
             funders in a given space.                    Meeting on Strengthening Research
                                                          Partnerships for Neglected Diseases of          WHO Director-General
             A complete briefing and link to the
                                                          Poverty in Berlin March 16-19 to discuss        congratulates China on
             document are available at:
                                                          a work plan and to agree on partners’           LF elimination
             www.who.int/tdr/svc/news-events/
                                                          responsibilities.
             news/g-finder-report n                                                                       WHO Director-General Margaret Chan
                                                          An ESSENCE website is being developed;
                                                                                                          congratulated China for its success in
                                                          it will be unveiled at the meeting
                                                                                                          having eliminated lymphatic filariasis
             ESSENCE tested in                            and launched shortly thereafter.
                                                                                                          (LF) as a public health problem in a
             country pilot                                This website will reinforce the fact
                                                                                                          recent ceremony in Beijing to celebrate
                                                          that although ESSENCE activities
                                                                                                          the landmark effort.
             Efforts of the new TDR-based initiative      are facilitated by TDR, ESSENCE was
                                                          initiated during a meeting organized            Noting China was historically one
             Enhancing Support for Effective
                                                          by the Sida, and it will extend beyond          of Asia’s countries with the highest LF
             National Capacity Efforts (ESSENCE)
                                                          TDR’s existing sponsors and partners to         burden, Chan said “China has acquired
             advanced with the staging of a country
                                                          involve other parties. Hannah Akuffo,           vast knowledge and experience over
             pilot meeting hosted in March by the
                                                          formerly of Sida, has been asked to act         the last five decades and [the country]
             Commission for Science and Technology
8            (COSTECH) of the United Republic of
                                                          as executive secretary of the initiative. n     capitalized on new strategies and tools
                                                                                                          as it mopped up the remaining trouble
             Tanzania.                                    Contact: Professor Hannah Akufo at
                                                                                                          spots in the country.”
             ESSENCE is an effort by a number of          Hannah.Akuffo@sida.se
             international funders to strengthen                                                          CP Ramachandran, one of the key
             research capacity in low-income                                                              architects of TDR’s LF research initiative
             African countries in the spirit of the       Good clinical laboratory                        that led to the development of key
             Paris Declaration on Aid Effectiveness.      practice published by                           new control tools and strategies in the
             The effort aims to harmonize their           WHO/TDR                                         1980s and 1990s, was among those
             respective efforts and improve                                                               present at the ceremony on 7 October
             transparency while increasing the                                                            2008. He provided an update on the
             involvement of disease-endemic                                                               ongoing Global Programme for the
             countries in combating neglected                                                             Elimination of LF, established by WHO
             diseases.                                                                                    in the wake of a 1997 World Health
             The Tanzania pilot meeting in                                                                Assembly resolution (WHA 50.29)
             Arusha on 9-10 March established                                                             calling for worldwide LF elimination
             a dialogue between donors and                                                                by 2020.

             country representatives about the
                                                                                                          An estimated 120 million people
             undertaking’s collaborative aspects. The
                                                                                                          globally are infected with the parasite
             meeting, held under the leadership of                                                        that causes LF, which is often cited as
                                                          From left to right, at the signing ceremony
             Hassan Mshinda, director general of          are Vanessa Grant (GCLP author), Joy Eldridge   the second leading cause of disability
             COSTECH, defined funder priorities and       (BARQA Publications Committee) Juntra           worldwide. n
             identified areas where activities may        Karbwang-Laothavorn (WHO/TDR), Andy
             overlap. Participants also agreed on         Ramsay (WHO/TDR) and Tim Stiles (GCLP
                                                          author).
             mechanisms that could lend synergy to
             future capacity-strengthening efforts,
                                                                                                          Longtime TDR affiliate
             according to Fabio Zicker, coordinator
                                                          TDR has obtained a copyright                    appointed WR in Gambia
                                                          agreement from the British
             of TDR’s Policy and Development (PAD)
                                                          Association of Research Quality                 Dr Thomas TY Sukwa, a longtime TDR
             portfolio and a TDR liaison to the effort.                                                   affiliate, has been named the WHO
                                                          Assurance (BARQA), permitting WHO
             Members of the initial ESSENCE               to publish and adapt BARQA guidelines           Representative (WR) for the Republic
             steering committee include the               on Good Clinical Laboratory Practice            of the Gambia, one of Africa’s smallest
             United Kingdom’s Department for              (GCLP). The agreement was signed at             countries with a population of
             International Development (DFID),            the Second Global Quality Assurance             approximately 1.6 million. The recipient
             Canada’s International Development           Conference in Edinburgh, 29-31                  of numerous TDR grants, Sukwa
             Research Centre, the Ministry of             October 2008. GCLP provides guidance            completed master’s and doctoral
             Foreign Affairs of the Netherlands, the      to laboratories analyzing samples               degrees in public health at Harvard
             Norwegian Agency for Development             from clinical trials. TDR will reproduce        University in 1983 and Johns Hopkins
                                                                                                                               No. 82
                                                                                                                               No. 82



University in 1992, both supported by     of the government’s commitment to           TDR’s Byron Arana
TDR.                                      strengthening the health sector. n          receives top Guatemalan
                                                                                      research award
                                          TDR grantee lauded                          Scientist Byron Arana, part of the TDR
                                          for TB research                             team on research to support visceral
                                          TDR grantee Dr Saw Saw, a native            leishmaniasis elimination, was the
                                          of Myanmar and a newly minted               2008 recipient of Guatemala’s highest
                                          PhD, was recognized last October            research award, the Science and
                                          for outstanding achievements in             Technology Medal.
                                          tuberculosis research with the
                                                                                      Arana, a medical doctor who
                                          Melbourne School of Population
                                                                                      holds a PhD in tropical medicine,
                                          Health’s annual Knowledge Transfer
                                                                                      received the award for his work
                                          Award. In order to be considered
                                                                                      on the epidemiology of cutaneous
                                          for the award, researchers must
                                                                                      leishmaniasis in Guatemala, studies on
                                          demonstrate that their work will
In the interim, Sukwa returned to                                                     the search for treatment alternatives,
                                          change health outcomes, policy or
his native Zambia to work as an                                                       and for his scientific contribution to
                                          professional practice; that it represents
epidemiologist with the Tropical                                                      national programmes for the control of
                                          a novel approach or major discovery;
Diseases Research Centre (TDRC),                                                      onchocerciasis and Chagas disease.
                                          and, that it embodies excellence in
then sponsored by TDR. He focused
                                          conceptualization, development,
on epidemiological and clinical
                                          execution and application of
research in schistosomiasis, human
                                          innovative, high-quality knowledge
African trypanosomiasis and malaria,
                                          transfer methods.
becoming director of the centre
in 1994. In 1999, he became senior        Through her doctoral work, Saw                                                       9
lecturer in community medicine at         Saw examined the role of public-
the University of Zambia’s School of      private partnerships in controlling
Medicine.                                 tuberculosis in vulnerable low-income
                                          populations in Myanmar. Her research
In 2000, Sukwa joined the WHO
                                          findings touched on several knowledge
Regional Office for Africa, where
                                          transfer issues, including the use of
he served as the medical officer for
                                          referral letters by general practitioners
malaria case management. There,                                                       The annual award by the Guatemala
                                          and the provision of health education
Sukwa developed a framework to                                                        National Council of Science and
                                          on TB at the township level.
guide countries through the adoption                                                  Technology (CONCYT) was presented
of new anti-malarial treatment policies                                               to Arana by the Vice-President of the
                                          Several of her recommendations, such
incorporating artemisinin-based                                                       Republic of Guatemala (Dr Rafael
                                          as disseminating health education
combination therapies (ACTs). He also                                                 Espada), also the CONCYT President,
                                          methods through former TB patients
developed a regional antimalarial drug                                                at a ceremony at the Guatemalan
                                          and establishing links between all GPs
resistance database.                                                                  National Congress on 18 November
                                          and the township health department,
                                                                                      2008.
                                          have been adopted by Myanmar’s
In 2005, Sukwa set up a Communicable
                                          national tuberculosis programme for
Diseases Research Unit within WHO/                                                    The award is given to a researcher
                                          improving the delivery of DOTS care.
AFRO, becoming Regional Advisor for                                                   for his or her contributions to
Communicable Diseases Research.                                                       the development of the scientific
                                          While a doctoral student at the
Following his involvement in TDR-                                                     knowledge and/or technology, based
                                          University of Melbourne, Saw Saw
sponsored high-level ministerial                                                      on the recommendations of an ad-
                                          worked with a longtime TDR adviser,
meetings in Abuja and Accra in 2006,                                                  hoc committee reviewing candidate
                                          Professor Lenore Manderson, and
he was re-assigned to head the WHO/                                                   nominations. Arana was nominated by
                                          co-supervisor Mridula Bandyopadhyay,
AFRO Tuberculosis Unit, a position he                                                 the Institute of Research, Universidad
                                          both of whom nominated her for the
held until his appointment as WHO                                                     del Valle de Guatemala, where he was
                                          award.
Representative in the Gambia in July                                                  co-director of the Centre for Health
                                          “Saw Saw’s research brings together         Studies prior to coming to TDR in May
2008.
                                          biomedical, social and cultural             2008. n
Speaking on behalf of WHO last            data and perspectives, ensuring
November, Sukwa applauded the             its dissemination and translation                    – Compiled with contributions
Gambia’s support and collaboration        into public health programs,” says                             from Patrick Adams
with the organization. He cited Vision    Manderson. “She continues to work
2020, the recently revised National       with the Myanmar Ministry of
Health Policy and the new Health          Health in controlling TB and has been
Master Plan as products of this           very successful in securing further
collaboration, which he called evidence   grants.” n
     The world of
         TropIKA.net is a web portal that aims to foster
                                                                         TropIKA.net
         innovation and knowledge application relating
         to the infectious diseases of poverty. In recent
         months, all the sections within TropIKA.net have                Selections from recent
         expanded considerably. The first of our specially
         commissioned TropIKA Reviews, comprehensively
                                                                         TropIKA.net web news
         addressing questions of key importance, will be
         published shortly.



      news about TropiKA.net                                             TropiKA.net at the 2008 Global Ministerial
                                                                         Forum on Research for Health




                                                                                                                                              Olivier Asselin
         More people are visiting www.TropIKA.net. There has
         been a steady rise in ‘hits’ over the last year; in a typical
         week there are now about 2000 visitors. However, we
         aim to improve on this figure, with the goal of making

10
         TropIKA.net the ‘one-stop shop’ for information and
         debate about infectious diseases of poverty. If you have
         not visited our knowledge platform yet, please do so. If
         you are already a regular user, please pass on the word to
         your colleagues.



      TropiKA.net ‘knowledge hub’ expands activities                     The Global Ministerial Forum on Research for Health, held
                                                                         17-19 November 2008 in Bamako, Mali, was our latest and most
      An important new initiative on TropIKA.net is our ‘knowledge       extensive knowledge hub effort to date (http://www.tropika.
      hub’ designed to facilitate sharing of information in a large      net/svc/home/bamako2008).
      international health forum with potential impact on the
                                                                         Our special 22-member TropIKA.net team in Bamako included
      battle against infectious diseases of poverty. The aim of this
                                                                         six journalists and twelve rapporteurs – from no fewer than ten
      ‘knowledge hub’ is to provide information both to participants
                                                                         countries. All rapporteurs were postgraduate research fellows
      and to engage members of the broader community with a
                                                                         from disease-endemic countries – this has been a strategic
      strong interest in the issues under discussion – so that even if
                                                                         choice of TropIKA.net providing young researchers with an
      unable to attend you may feel “virtually” present.
                                                                         opportunity to participate in international policy fora.
      Before the meeting, background documents are made
                                                                         “There is a lot of value in this approach,” said Nicole Biros, who
      available online and dedicated collaborative workspace is
                                                                         coordinated the TropIKA.net ‘knowledge hub’ for Bamako. “It
      offered to organizers, presenters and other interested parties/
                                                                         greatly benefits the team’s reporting that the rapporteurs are
      communities of practice.
                                                                         not only familiar with the science involved, but also with the
      During the meeting, daily overviews are posted by a special        social and contextual realities that are an integral part of the
      TropIKA.net team of journalists and rapporteurs. The team puts     issues being discussed.”
      together session reports, comprising analytical summaries
                                                                         The rapporteurs also build up new skills and diversify
      of issues and viewpoints, as well as links to the formal
                                                                         their interests as they experience these events not only as
      presentations, session conclusions and recommendations.
                                                                         researchers but as professional communicators who have to
      Profiles, interviews and a meeting blog are also featured on the
                                                                         provide information on research to a broader public. They
      website, as are photographs. After meetings are over, TropIKA.
                                                                         thus lend a unique perspective to their collaborations with
      net continues to maintain the ‘knowledge hub’ for ease of
                                                                         TropIKA.net’s journalists, who are in charge of the reports’ final
      reference and further follow-up/perspectives on the event and
                                                                         writing and editing. The Bamako team also was well-served
      the issues. n
                                                                         by these journalists’ diversity (half are based in Africa). Senior
                                                                         researchers from renowned institutions in Brazil, Ghana and
                                                                         Mali also worked with the knowledge hub, acting as arbiters
                                                                         on the review and editing of final reports. They, together with
                                                                         the knowledge hub’s collaborators from another cooperating
                                                                         agency, UNESCO, proved to be major assets to the undertaking,
                                                                         providing the team with valued regional perspectives and
                                                                         policy insights.

                                                                         For the Bamako meeting, the team produced three daily
                                                                         overviews and 41 session reports. There were also seven news
                                                      TropIKA.net                                                                                      No. 82



stories, one profile, and four entries to the blog. The final        be produced and distributed to interested parties. Through
Bamako Call for Action, adopted by 53 countries represented          the knowledge hub effort, TropIKA.net offers a space where
at ministerial level, is also available on the TropIKA.net website   health research forums can open up to real-time universal
(http://www.tropika.net/svc/specials/bamako2008/call-                participation. On this site information and knowledge can
for-action/call).                                                    flow back and forth, evolve and be stored, updated and easily
                                                                     retrieved. The network is an independent forum where issues
One impact of the ‘knowledge hub’ coverage was a tripling of
                                                                     can be debated and moved forward with equitable access by
the number of TropIKA.net website visitors during the period of
                                                                     all stakeholders.
the meeting and for days thereafter – evidence of the real need
that the service was able to meet. The Bamako ‘knowledge             TropIKA.net plans more knowledge-hub participation at
hub’ section will remain on the TropIKA.net website as a readily     important health forums in 2009 and will post details of such
accessible source of information on the event and a place            forthcoming events. If you think this knowledge-hub approach
where comments can still be posted. The regular TropIKA.net          could enhance a planned health forum event on infectious
team continues to add information via the blog when reference        diseases of poverty in which you are involved, or if you are
is made to the meeting in the press or elsewhere. A CD-ROM           interested in participating on the knowledge hub initiative as a
compilation of all Bamako knowledge hub contributions will           rapporteur, please contact: Edith Certain, certaine@who.int.




selections from other TropiKA.net features
The world can well                  vector control strategies;       appear every month and we         we publish a summary, with
                                    we will be combining these       will soon be increasing this      commentary on each report
afford the malaria
                                    with bednets and diverse         number. We have reported          and include a link to the
vaccine                             public health measures. The      on developments from              document itself. This could
A distinguished malaria             combination will gradually       Cambodia to Colombia, and         be one of the most important
researcher says that a              bring this wiliest of foes       on diseases that range from       functions of our project.
shortage of funds should            under control.” n                dengue to dracunculiasis.         Examples of reports we have
not stand in the way of                                              Stories involving the             recently featured include:
                                    http://www.tropika.
developing an effective                                              innovative use of technology      •	 Meeting the Malaria
                                    net/svc/editorial/gn/
malaria vaccine. In an address                                       are also featured. So if you         Treatment Challenge, the
                                    nossal20080331
to the Molecular Approaches                                          want to know the latest              Artemisinin Enterprise;
to Malaria Conference, Lorne,                                        developments in the fight         •	 Good Practices in Health
Victoria, Australia – also          People at the top talk           against infectious diseases          Financing, International
published as an Editorial                                            of poverty, browse here:             Bank for Reconstruction
                                    to TropiKA.net                   (http://www.tropika.net/             and Development (World
Opinion on TropIKA.net –
Sir Gustav Nossal said that         Our profiles section             svc/collection/news/).               Bank):
researchers have achieved           (http://www.tropika.net/                                           •	 The World Can’t Wait:
                                    stakeholders/) features a                                             More Funding Needed for
things that 25 years ago                                             From the journals
would have been thought             monthly interview with                                                Research on Neglected
                                    a leading figure working         We select for summary and
impossible. Research funding                                                                              Infectious Diseases, Families
                                    against infectious diseases      comment articles in peer-
has also now reached a high                                                                               USA;
                                    of poverty. Our interviewees     reviewed journals that we
level. He cautioned that it                                                                            •	 Cough up for TB!: The
                                    have included researchers,       regard as being of particular
is not only money that is                                                                                 Underfunding of Research
                                    clinicians, agency executives,   importance. Review and
needed, “We need better and                                                                               for Tuberculosis and Other
                                    academics and people in          opinion articles are included
more benign governance                                                                                    Neglected Diseases by the
                                    industry. We ask them about      as well as original research.
structures in the developing                                                                              European Commission,
                                    their work, achievements         Nearly 400 articles have been
countries and a great deal                                                                                Médecins Sans Frontières.
                                    and outstanding                  included in this coverage.
less corruption. We need to
                                    challenges. These in-depth
forge true partnerships with
                                                                     Reports                           The TropiKA.net blog
                                    interviews often elicit
developing countries with                                                                              The blog offers an
                                    surprising information and       Journal articles are indexed
their scientists and health                                                                            opportunity to comment on
                                    controversial comments.          on PubMed and other
officials putting major input                                                                          articles that have appeared
                                    Experts profiled recently        databases, and therefore
into the programmes. We                                                                                on TropIKA.net and on
                                    included Chetan Chitnis of       specific topics are easy to
need better physical and                                                                               developments elsewhere.
                                    the International Centre for     search. However, when
human infrastructure in most                                                                           The editorial team also uses
                                    Genetic Engineering and          organizations produce
of the developing countries.”                                                                          the blog to alert readers to
                                    Biotechnology in India; Claire   reports these often go
Sir Gustav also warned of the                                                                          interesting items published
                                    Panosian Dunavan, outgoing       unread because there is
dangers of overpromising;                                                                              elsewhere on the internet.
                                    president of the American        no comparable index or
it is important to speak            Society for Tropical Medicine                                      A surprising range of topics
                                                                     register of such documents.
of control rather than              and Hygiene; and Larry Geiter                                      have been covered recently,
                                                                     TropIKA.net uses a variety
eradication. Nevertheless, he       and Charles Wells of Otsuka                                        from the inspiring (an
                                                                     of resources to identify
concluded that, “...if malaria      Pharmaceuticals.                                                   Indian project to provide
                                                                     new reports that relate to
researchers do their work                                                                              employment for leprosy-            Contacts:
                                                                     the infectious diseases of
well, then over the next                                                                               cured patients) to the bizarre
                                    TropiKA.net news                 poverty.                                                             Dr Ayaode MJ Oduola,
decade or two we will have a                                                                           (a campaign to ‘save the
                                                                                                                                          oduolaa@who.int
malaria vaccine that works;         The news section has             In our reports section            Guinea worm’). Responses to
we will have more and better        expanded at a remarkable         (http://www.tropika.net/          the blog entries are warmly        Ms Edith Certain,
drugs; we will have smarter         pace. At least ten new stories   svc/collection/report/)           welcomed. n                        certaine@who.int
          No. 82                                          Cover story | Bamako 2008



                       The Bamako 2008 Global Ministerial Forum
                       on Research for Health


                       Making a
                       paradigm shift
                       Health is the product of a complex social and environmental system that requires research and devel-
                       opment spanning many fields – not simply the product of the presence or absence of disease and the
                       medical ability to treat and prevent it. This was the message underlying the Global Ministerial Forum
                       on Research for Health, 17-19 November 2008 in Bamako, Mali. The forum on the theme of “research for
                       health” brought together researchers, policy leaders and civil society representatives from around the
                       world, as well as leaders from other sectors ranging from environment and agriculture to security, sociol-
                       ogy and economics.
12



     Row 1: President Amadou Toumani Touré of the
     Republic of Mali opening the forum.
     Row 2: Luis Sambo, Regional Director, World
     Health Organization Regional Office for Africa;
     Robert Ridley, Director, TDR
     Row 3 (on left): Ok Pannenborg, Senior Adviser
     to the World Bank and representative to TDR’s JCB.
                          Cover story | Bamako 2008                                                                                                No. 82
                                                                                                                                                   No. 82



BAMAKO – In a dusty health centre a few hours south                                     science, agriculture, climate, food security, economics,
of Mali’s capital, Bamako, a health worker pricks the                                   politics, energy and trade. Some 1100 participants from
finger of a feverish little boy, squeezes blood into a ma-                              75 countries attended, including official delegations
laria test strip, and waits until the result appears. It’s a                            from 53 countries led by ministers of health, education
seemingly simple process – and yet 1 million African                                    and technology.
children still die every year from malaria because they
                                                                                        This broad base of involvement also was reflected in
do not get adequate diagnosis and treatment.
                                                                                        the joint organization of this year’s forum by six part-
The tragedy of malaria is not a new story, rather an old                                ners: the Council on Health Research for Development
one, that nonetheless illustrates the continuing failure                                (COHRED), the Global Forum for Health Research, the
of health systems to influence or manage the complex                                    World Bank, the World Health Organization (WHO),
chain of social, cultural, environmental and economic                                   the United Nations Educational, Scientific and Cultural
factors required to transfer research knowledge to pol-                                 Organization (UNESCO) and the host country, the Re-
icy and practice.                                                                       public of Mali.
Where health researchers and policy-makers have most                                    In a keynote presentation, Luis Sambo, director of
often failed is in taking a holistic, systemic approach                                 WHO’s Regional Office for Africa, called for “the right
to fighting disease, says George Amofa, Ghana’s deputy                                  kind of research, now more than ever”. He cautioned
director-general of health services, speaking at the re-                                that health research should not be considered a drain
cent Global Ministerial Forum on Research for Health                                    on resources but rather a producer of economic gains,
in Bamako.                                                                              citing a 2001 report of the Commission on Macroeco-
                                                                                        nomics and Health. “We need research to guide health
It was out of this emerging awareness that an agenda
                                                                                        system reforms, as we have seen here in Mali. We need
for Strengthening Research for Health, Development
                                                                                        operational research to help give existing interventions
and Equity was formulated as the focus of the Bamako
                                                                                        a greater impact. Above all, we need research to per-
discussions – bringing together for the first time stake-
                                                                                                                                                   13
                                                                                        suade the world that investments in health must con-
holders not only from the health sector, but also from
                                                                                        tinue as one of the surest and best proven routes to a
                                                                                        stable and prosperous global society.”
                                                               Photos Olivier Asselin




                                                                                        Multi-disciplinary approaches
                                                                                        to health
                                                                                        The forum recognized that in order to fight priority
                                                                                        diseases and improve the health of the world’s poor,
                                                                                        policy-makers and researchers must address the de-
                                                                                        terminants of health that lie beyond disease control,
                                                                                        prevention and treatment. Sessions on the impacts of
                                                                                        pandemics, global warming, food shortages and mili-
                                                                                        tary conflicts offered insights into new approaches and
                                                                                        models.
                                                                                        “Between 40% and 60% of health outcomes can be ex-
                                                                                        plained by forces from outside of the immediate health
                                                                                        arena,” said Ok Pannenborg, a senior World Bank ad-
                                                                                        viser and the World Bank Representative to TDR’s Joint
                                                                                        Coordinating Board (JCB). These challenges range
                                                                                        from weak supply chains that make it difficult for re-
                                                                                        mote populations to access pharmaceuticals and other
                                                                                        health tools to lack of reliable and affordable health
                                                                                        services, unreliable food sources, poor environmen-
                                                                                        tal health conditions related to unsafe drinking water,
                                                                                        inadequate sanitation and poor housing, and climate
                                                                                        change threats related to increased patterns of drought
                                                                                        and flooding.
                                                                                        “All these concerns transcend the boundaries of typical
                                                                                        health sector parameters,” said Pannenborg. “Neverthe-
                                                                                        less, they strongly influence human health.”
                                                                                        “Malaria is an example of a health issue that requires a
                                                                                        broader, systemic approach, just like HIV/AIDS,” said
                                                                                        TDR Director Robert Ridley, chairman of a Bamako
                                                                                        session on Pandemics and Infectious Diseases orga-
                                                                                        nized by TDR (see Box 1 on next page).
     No. 82                            Cover story | Bamako 2008



                    BOX 1. Pandemics and infectious diseases


                    Considering the links between poverty and dis-         he said, is to assist countries to build this national
                    ease was the aim of a TDR-sponsored session on         capacity.
                    pandemics and infectious diseases at the Bamako
                                                                           Development of regional capacity for clinical R&D
                    2008 meeting.
                                                                           is also a priority, according to Mark Walport of the
                    George Amofa of Ghana’s health service argued          Wellcome Trust. Collaboration, including among
                    that the malaria pandemic has been largely             countries in regions sharing common health
                    ignored despite the fact that more than 1 million      issues, is essential to successfully overcome the
                    people annually die from the disease, with 90%         challenges that infectious diseases and pandem-
                    of those deaths in sub-Saharan Africa.                 ics present, including scientific challenges (e.g.
                                                                           transmission routes and viral ecology or effec-
                    “We must take a systemic approach to malaria,
                                                                           tive field diagnostics), logistical challenges (e.g.
                    looking at areas of research beyond the typical
                                                                           supply lines and location of stockpiles, large-scale
                    boundaries of health,” said Amofa. He proposed
                                                                           delivery) and communication challenges (e.g. con-
                    a range of measures to take, including develop-
                                                                           veying the risks of the disease to the public).
                    ing a surveillance system for early detection of
                    and response to outbreaks, designing better and        Maria Guzman, virology chief at the Pedro Kouri
                    more reliable diagnostics as well as communica-        Tropical Medicine Institute, spoke on how Cuba
                    tion strategies to promote behaviour changes,          – a country with a low GDP – has found success
                    and improving supply chains for antimalarials,         in addressing the problem of pandemics. Cur-
                    insecticide-treated bednets and diagnostic test-       rently, infectious diseases only attribute for 8.8%
                    ing kits.                                              of mortality in the country. Cuba’s approach is
14                  It remains important to ensure that research re-
                                                                           anchored in the recognition of the universal right
                                                                           to health and education. Elimination campaigns
                    sults are translated into policy and action, Amofa
                                                                           for diseases such as polio, malaria and TB have
                    said. Citing Ghana as an example, he noted that it
                                                                           involved mass immunization programmes and
                    took many years for research demonstrating the
                                                                           distribution of free medications, such as antiret-
                    effectiveness of bednets in preventing malaria
                                                                           rovirals for people with HIV/AIDS, by the public
                    transmission to be translated into policies pro-
                                                                           health system. The keys to success, she said, have
                    moting mass bed-net distribution.
                                                                           been political will, adequate funding, strong
                    TDR Director Robert Ridley said that for research      surveillance and epidemiological monitoring,
                    to have an impact on diseases such as malaria,         policy support for health and scientific research,
                    and thus on poverty, the global health commu-          and strong human research and medical staff
                    nity also must address the gap between scientific      capacity, as well as other features found in free-
                    research and product development. Basic knowl-         of-charge national health systems. n
                    edge must be translated into usable products and
                    strategies, particularly ones designed for poorly      For more details and resources, see:
                    resourced environments. Countries also lack            http://www.tropika.net/svc/specials/
                    capacity to find solutions to their own specific       bamako2008/session-reports/
                    problems, Ridley noted. One of the roles of TDR,       pandemics-and-infectious-diseases




              He called for available tools and knowledge to be har-       vising evidence-based responses, as well as monitoring
              nessed into workable delivery strategies designed for        and measuring those responses’ impacts and benefits.
              specific environments.
              Meeting the maternal health Millennium Development           Making ‘research for health’ a reality
              Goal (MDG 5) will require an approach that extends
              beyond conventional health research, said Catherine          For three days, the forum discussed and debated ‘re-
              Sanga, the United Republic of Tanzania’s assistant di-       search for health’ as a way of improving the health of
              rector for reproductive and child health in the Ministry     the world’s poor. The challenge is to turn this “into a
              of Health and Social Welfare.                                reality, not just a dream”, said Anthony Mbewu, presi-
                                                                           dent of South Africa’s Medical Research Council. The
              “Not only do we need to invest in health systems in          resulting Bamako Call to Action on Research for Health
              order to see improvements, we need socio-cultural re-        details the forum’s proposed solutions (http://www.
              search to find out why home delivery rates are so high,
                                                                           tropika.net/svc/specials/bamako2008/call-for-action/
              and then how to better support women so that they
                                                                           call), some of which are briefly discussed below.
              come to hospitals for prenatal care and delivery.” This is
              where research can play a critical role by showing how       Funding – Many conference participants noted that
              systems impact on health, measuring problems and de-         while funding for research and control of particular
                               Cover story | Bamako 2008                                                                              No. 82
                                                                                                                                      No. 82



                                                                          As part of this national research strategy, countries
                                                                          need to support local research institutions and develop
                                                                          their personnel’s capacity to “undertake, understand,
                                                                          translate and interpret research”, he said.
                                                                          In Mali, for example, there are several centres of ex-
                                                                          cellence for research in health and agriculture, with
                                                                          researchers working on important local issues such as
                                                                          drug resistance in malaria. However, most research for
                                                                          health in Mali is dependent on external funding, and
                                                                          thus at risk of being part of an external organization’s
                                                                          research agenda.
                                                                          Suggestions from the forum included the creation of
From left to right: Stephen Matlin, executive director of the Global
                                                                          a national research centre that would set the national
Forum for Health Research; Tim Evans, assistant director-general, WHO/    health research agenda and coordinate research ef-
IER and Roger Glass, director of Fogarty International Center, National   forts. In addition, the Malian government would need
Institutes of Health, USA.                                                to significantly increase its budgetary commitment for
                                                                          research. Research receives 0.15% of GDP, well below
                                                                          the 2% of GDP recommended by the Bamako Call to
diseases, for example HIV/AIDS, is available and often                    Action.
fairly accessible, funding to develop health systems is
less easy to come by.                                                     The importance of expanding local health industries
                                                                          was also recognized. Initiatives like the Yaoundé Pro-
“Funding is often driven by vertical lines, and if you                    cess are mapping health innovation activities in Africa
want research funding to collaborate across sectors and                   by looking at specific needs of African countries in de-
                                                                                                                                      15
disciplines, it’s a challenge”, said Stephen Matlin, exec-                veloping local R&D, manufacturing and distribution of
utive director of the Global Forum for Health Research.                   vaccines, pharmaceuticals and diagnostic tests.
The Call to Action urges national governments to al-                      Monitoring/evaluation and implementation/oper-
locate at least 2% of their health ministry budgets to                    ational research – Sometimes described as the “poor
research. Funders of research and innovation and in-                      sister” of research, monitoring and evaluation (M&E) is
ternational development agencies are asked to invest at                   a routine evaluation of programme performance based
least 5% of development budgets in health research.                       on pre-established indicators such as coverage, surveil-
One Indian initiative is addressing a lack of obstetri-                   lance, lag time to action and distribution of drugs. A
cians in remote areas by paying private practitioners to                  somewhat related field, implementation/operational
provide maternity services to poor women. KV Ramani                       research (IR/OR), typically examines how to overcome
of the Centre for Management of Health Services at the                    bottlenecks in programme performance and how to
Indian Institute of Management said this scheme has                       scale up programmes more effectively. Health policy-
already saved the lives of almost 8000 newborns.                          makers increasingly recognize these efforts as key to
                                                                          the improvement of health systems. At Bamako, TDR
“We also need to address issues of transportation to the
                                                                          and the Global Fund to Fight AIDS, TB and Malaria
hospital, national insurance for people living below the
                                                                          co-sponsored special sessions on implementation/op-
poverty line, the lack of midwives, poor blood bank
                                                                          erational research (see Box 3) and on monitoring and
management and so on”, said Ramani. “All these issues
                                                                          evaluation (see Box 2).
represent research questions that require funding”.
                                                                          The United Republic of Tanzania offers a relevant ex-
Country-led research strategies – Research priorities
                                                                          ample of how research can lead to policy change, ma-
often have been defined by donors. The forum’s Call
                                                                          ternal health expert Sanga noted in a session on the
to Action recommended that “the global research for
                                                                          Millennium Development Goals and health. Her gov-
health agenda should be determined by national and
                                                                          ernment’s research examined whether Integrated Man-
regional agendas and priorities”.
                                                                          agement of Childhood Illness (IMCI) improves pae-
“This is the only way we can be sure that the research                    diatric care quality as well as this care’s affordability
questions asked are relevant to the countries them-                       and child survival rates. IMCI typically is delivered as
selves”, said conference participant Fiona Godlee, edi-                   a package of interventions to address major childhood
tor in chief of the British Medical Journal.                              illnesses (e.g. malaria, pneumonia and diarrhoea). It
                                                                          includes assistance to health workers to improve case
“We need research that focuses on the needs of the
                                                                          management, effective drug supply and management,
population”, said Martin McKee of the Brussels-based
                                                                          and improved hospital care through better supervision
European Observatory on Health Systems and Policies,
                                                                          and timely referrals.
a partnership of the WHO Regional Office for Europe
and over a dozen governments, development banks                           The study found that districts using IMCI had a better
and academic institutions. “This means doing context-                     quality of care with a lower cost per child and lower
specific research. To do this, countries need a national                  child mortality than districts that had not implemented
research strategy,” McKee said.                                           IMCI. Sanga said, “Looking at these results, you could
     No. 82                                 Cover story | Bamako 2008



                    BOX 2. Monitoring/evaluation for research

                    A parallel session on monitoring and evaluation            The Ethiopia team, however, found that invest-
                    drew a heavy attendance at Bamako, underlining             ments in PMTCT services had had a limited
                    the new relevance being attached to the topic by           impact in terms of their availability and actual
                    health researchers and policy-makers as a means            uptake of services. The team identified a need to
                    to improve health services.                                collect data on survival rates and quality of life
                                                                               of patients on antiretroviral therapy (ART), the
                    This session, sponsored by the Global Fund to
                                                                               sero-prevalence of HIV in high-risk populations,
                    Fight AIDS, TB and Malaria in partnership with
                                                                               and the incidence and prevalence of TB (the most
                    TDR, described the preliminary outcomes of a
                                                                               current data are five years old).
                    five-year evaluation of disease control activities
                    conducted under the auspices of the Global Fund            In Malawi, the evaluation showed that the preva-
                    in disease-endemic countries.                              lence of HIV had been reduced from 14.7% in 2003
                                                                               to 12.6% in 2007, and that the number of people
                                                                               on ART had increased from 13 000 in 2004 to
                                                                               146 000 in 2007. However, the massive focus on
                                                                               ART had diverted attention and funds from other
                                                                               major killers such as malnutrition and mater-
                                                                               nal and child mortality (due to eroding health
                                                                               systems).
                                                                               After completing its evaluation, the Zambia
                                                                               team recommended improving data collection
                                                                               to understand what was driving major trends.
16                  Rolf Korte, Technical Evaluation Research Group (TERG),    Was the declining child mortality, for example,
                    Gesellschaft fur Technische Zusammenarbeit (GTZ)           due to improved health education of mothers, an
                                                                               increase in breastfeeding, or the mass distribu-
                    There were four presenters from Burkina Faso,              tion of bednets?
                    Ethiopia, Malawi and Zambia. Each country team
                                                                               All country teams concluded that M+E findings
                    found that routine health information systems
                                                                               must be better disseminated and data/findings
                    were generally very poor, and that more baseline
                                                                               used more effectively in decision-making. The
                    data must be collected in the future. However,
                                                                               final evaluation report is due out in May 2009. n
                    all teams felt that despite gaps in the data, the
                    information they did collect could be used locally
                    to motivate staff to improve health centres.               For more details and resources, see:
                    In Burkina Faso the evaluation team identified             http://www.tropika.net/svc/specials/bama-
                    particular issues, such as poor access (14%) to            ko2008/session-reports/monitoring-evaluation
                    Prevention of Mother to Child Transmission of
                    HIV (PMTCT) services in the country, and rising            http://www.theglobalfund.org/documents/
                    incidences of TB and malaria.                              me/M_E_Toolkit_lores_en.pdf



              argue that IMCI could save the lives of 28 000 children         Bamako Call to Action, which stated that “the nature
              in Tanzania each year.” She said the research already           of research and innovation for health improvement ...
              has resulted in rapid scale-up of IMCI.                         is not sufficiently inter-disciplinary and inter-sectoral.”

              Marie Ruel, Food Consumption and Nutrition division             The forum sought to improve dialogue between dif-
              director at the International Food Policy Research Insti-       ferent government agencies (e.g. health, finance and
              tute (IFPRI), noted the importance of using such tools          agriculture) on common concerns, as well as between
              to measure health system performance and to identify            policy-makers, research leaders and civil society orga-
              best practices. “Monitoring and evaluation and imple-           nizations. The Call to Action stressed the need for civil
              mentation research are the types of research where we           society and community participation in the research
              can learn valuable lessons,” she said. “This is the type of     process, and in making key decisions to do with re-
                                                                              search and investment.
              data can be used to scale up and replicate programmes
              elsewhere.”                                                     “Communities need to be empowered through re-
                                                                              search, and not disempowered, as often happens,”
              Moving intersectorality                                         said Thelma Narayan, a Society for Community Health
                                                                              Awareness, Research and Action (SOCHARA) public
              ‘Intersectorality’ was another buzz word at the forum.          health consultant in India. “Our dependence on ex-
              The importance of this theme was underlined in the              perts needs to give way to a more participatory form
                         cover story || CDI study
                         Cover story Bamako 2008                                                                                 No. 82



of research, where communities are not just objects to
be studied, but active participants and subjects in the
research process”.
Mbewu of South Africa’s Medical Research Council
suggested that national AIDS councils in South Africa,
which mobilize and coordinate activities across all sec-
tors of society in the fight against HIV/AIDS, could be
used as an example of effective intersectoral coordina-
tion.


Innovation for health
The final Bamako communiqué stressed innovation for
                                                            Gil Samuels, Chair of Global Forum for Health Research and Carel
health – not only in the product R&D chain but also in      IJsselmuiden, Director, Council on Health Research for Development
developing systems, strategies and solutions to address     (COHRED).
issues ranging from gender equality to patient safety and
health communications/education.                            tion may help engage the African private sector more
                                                            fully to deliver services, train health workers, manage
New ideas in the communiqué included the creation
                                                            supply chains and manufacture health care tools and
of “convergence centres” linking universities, start-up
                                                            equipment. Yet the forum’s communiqué also appealed
companies and venture capital, and the strengthening of
                                                            to the private sector to engage more proactively with
e-health initiatives. Some of these are based on simple
                                                            other stakeholders. It called upon researchers to improve
but innovative software technologies accessible through
                                                            their translation of research results into commonly un-
mobile phones.
                                                            derstood terms and messages, and for policy-makers
New investments by the World Bank Group, the Bill and
Melinda Gates Foundation and the Rockefeller Founda-
                                                            to use research more effectively to guide decisions on
                                                            health policy.
                                                                                                                                 17


      BOX 3. Implementation/0perational research

      This special session emphasized the increasing         TDR Strategic Alliances Coordinator Jane Frances
      importance of operational and implementation           Keyenga-Kayondo spoke about TDR’s role in build-
      research (OR/IR) in determining how well health        ing in-country research capacity. “This type of
      programs are working and how they can be im-           research is important,” she said, “because proven
      proved. As one presenter said, “You can distribute     disease control tools fail, and often it’s not known
      bednets, but if you don’t know what’s happening        why. You need evidence at every stage and in all
      to them and if they are being used, your money         settings to improve the quality of interventions.”
      and time is going to waste.”
                                                             The session recommended that OR/IR play a more
      The forum heard that OR/IR can help identify and       pivotal role in national health services and in
      solve problems in implementation, help policy-         donor-funded disease control programmes. The
      makers reach evidence-based decisions, improve         capacity of researchers to conduct this type of re-
      program quality, strengthen public health efforts      search also should be increased. The Global Fund
      and help staff understand why and how well             has already encouraged the inclusion of OR/IR in
      their programmes are working. OR/IR can also           the programmes it supports, and has produced a
      identify new directions in health programming.         framework available on its and TDR’s websites to
                                                             guide OR/IR researchers in good practices. n
      Irene Akua Agyepong, Greater Accra regional di-
      rector in Ghana’s Health Service, described recent
      operational research undertaken to find out why,
      in 2002, bed-net use across Ghana was very low.
      Initial research showed that bednets were not          For more details and resources, see:
      available for purchase in the markets, which led       http://www.tropika.net/svc/specials/bama-
      to their free provision. However, further research     ko2008/session-reports/implementation-opera-
      revealed that children under five, who are at          tional-research
      high risk from malaria, were still not sleeping
                                                             http://www.theglobalfund.org/documents/me/
      under the nets. This was a powerful indication
                                                             FrameworkForOperationsResearch.pdf
      of the need to understand the complex factors
      that influence bednet use and to adapt interven-       http://www.who.int/tdr/svc/publications/
      tions accordingly, via education and other social      training-guideline-publications/framework-
      measures.                                              operation-research
     No. 82                                Cover story | Bamako 2008



                    BOX 4. MRTC is African model for research training


                                                                                      MRTC Co-director Ogobara K Doumbo is also the
                                                                                      head of a vaccine-testing programme, oper-
                                                                                      ated jointly with the NIH Laboratory of Parasitic
                                                                                      Diseases. A staff of more than 50, nearly all from
                                                                                      Mali, carries out research on malaria control, as
                                                                                      well as on filariasis and leishmaniasis. From 1992-
                                                                                      2008 the MRTC staff published, with internation-
                                                                                      al collaborators, more than 240 peer-reviewed
                                                                                      articles in highly regarded journals.
                                                                                      Yéya Touré, currently leader of TDR’s vector
                                                                                      control research activities, was MRTC’s found-
                                                                                      ing director and remained there until 2001. The
                    Mamadou Coulibaly of the MRTC, also profiled in the article on
                                                                                      center is now co-managed by Doumbo and Sékou
                    biosafety course on page 32.
                                                                                      Fantamady Traoré.
                    Mali’s Malaria Research and Training Center                       The center was one of Africa’s first to develop a
                    (MRTC) was a much-visited site by participants                    molecular biology unit and focuses on Anopheles
                    at the Bamako 2008 Global Ministerial Forum.                      gambiae, the region’s main carrier of malaria.
                    The center, dedicated to research on malaria and                  There are 12 research groups with laboratories,
                    other vector-borne diseases, provides a useful                    all led by Malian PhDs and funded by research
                    model for other countries.                                        grants.
18                  MRTC aims to build capacities in entomology,                      A bioinformatics unit was established with initial
                    molecular biology and epidemiology; to research                   funding by TDR for two-week training sessions.
                    malaria control; and to collaborate internation-                  The NIH now provides computers and sends
                    ally to develop vaccines. It was established in                   scientists to teach the course. TDR funds 10 to
                    1992, preceding by two years the founding of the                  15 trainees, and then selects and funds two of
                    University of Mali (which changed its name to the                 the top research proposals coming out of this
                    University of Bamako in 2000).                                    training. Other TDR contributions include support
                                                                                      for development of mass treatment and vector
                    The center was established through collaboration
                                                                                      control strategies, for characterization of filariasis
                    between the School of Medicine and Pharmacy
                                                                                      transmission and for research into schistosomia-
                    (now Faculty); the USA-based National Institutes
                                                                                      sis and drug resistance. n
                    of Health (NIH) and the Rockefeller Foundation;
                    and WHO/TDR. NIH remains the main supporter
                    while current partners include Mali’s health                          – By Jamie Guth in Bamako, with a contribution
                    ministry, TDR, WHO, Institut Pasteur, the Gates                                         from Beverly Stearns Peterson
                    Foundation and universities in the USA, Europe
                    and Africa.




              “Research should not substitute for action,” said the                  dialogue launched at Bamako in the spirit of a common
              World Bank’s Pannenborg. “We need to ensure that                       understanding that health is a critical investment in de-
              countries implement policies as a follow-up to research.”              velopment. “All of the ministers of health, research, sci-
                                                                                     ence and technology, education, food and agriculture,
              Clearly, however, international and donor organizations
                                                                                     and environment here must continue their dialogue
              also must play leadership roles. In light of that need, the
                                                                                     once they return home and coordinate their efforts in
              Swedish International Development Agency (Sida) is
                                                                                     all programmes that affect health,” Mbewu said. y
              leading ESSENCE, a new initiative supported by TDR to
              bring donors together in a more harmonized approach
              (see TDRbriefly, p. 8). A TDR-led stakeholder meeting                     For more details from the forum, including session and daily
                                                                                        reports, profiles of key players, the call to action and communiqué,
              16-18 March is also addressing the all-important topic
                                                                                        and coverage of earlier regional meetings that fed into this forum,
              of donor coordination.                                                    see: http://www.who.int/tdr/topics/ir/cdi.htm

              In November 2009, Bamako’s participants will review
              progress so far at the Global Forum for Health Re-                           Contacts:
              search annual meeting, Forum 2009: Innovating for                         Dr Jane Kengeya-Kayondo (OR/IR and M&E sessions)
                                                                                        kengeyakayondo@who.int
              the Health of All, in Havana, Cuba. Mbewu of South
                                                                                        Jamie Guth
              Africa’s Medical Research Council said that until then,
                                                                                        guthj@who.int
              forum participants should continue the intersectoral
                                               Focus | Capacity building in Liberia                                                                     No. 82




                 ‘Greening’ a clinical trial site in a remote area

                 Reviving research in Liberia
                 The TDR-sponsored Phase III clinical trial for moxidectin, a new drug candidate and potential cure for on-
                 chocerciasis, is one of the largest undertakings in TDR’s history. Funded largely by a US$ 6 million donation
                 from Wyeth Pharmaceuticals and contributions from the African Programme for Onchocerciasis Control
                 (APOC), the initiative is not only testing a new drug for river blindness. It is building research capacity and
                 stimulating sustainable development in countries recovering from conflict. In fact, mud brick construction
                 of a modern clinical trial center in a remote corner of Liberia, as well as pursuit of clean solar and hydro-
                 electric energy for the Liberian and Democratic Republic of Congo sites, make the trials potential models
                 of environmental sustainability in the health sector. For TDR scientist Annette Kuesel, the project has been
                 a journey down a road marked by unforeseen challenges and unexpected rewards.
AFRO/LBR/Bolay




                                                                                                                                                        19




                 Community manufacturing of the sun-dried mud bricks for the research centre.



                 It was a muggy mid-November afternoon in 2008                              The US$ 8.5-million Phase III clinical trial and capacity
                 when Kuesel arrived at Roberts International Airport,                      building effort, supported by the US$ 6 million Wyeth
                 35 miles south of Monrovia. In June 1990, Robertsfield                     donation and contribution from APOC is due to begin
                 as locals call it, had been the focus of a fierce battle                   this spring and summer and continue for three years.
                 between rebels and government forces. The badly dam-                       It is being carried out in remote areas of Africa not yet
                 aged main terminal still stood vacant, while across the                    reached by the annual ivermectin treatments currently
                 tarmac several UN planes unloaded supplies for the                         used to combat the disease in much of sub-Saharan Af-
                 14 000 peacekeepers still scattered throughout the                         rica.
                 country.                                                                   Of the study’s four sites, two are in the Democratic Re-
                 Kuesel had come with Varalakshmi Elango, a labora-                         public of Congo, one is in Ghana, and one is in Bola-
                 tory physician and TDR clinical monitor, to work with                      hun, Liberia. The latter is a small, battle-scarred vil-
                 a team of researchers from the Liberian Institute of Bio-                  lage in Lofa County, just a few kilometers from Liberia’s
                 medical Research finalizing preparations for the Phase                     northern border with Guinea and Sierra Leone.
                 III clinical trial of moxidectin. Moxidectin is a drug                     Setting up a clinical trial in a remote setting is a com-
                 candidate for onchocerciasis (river blindness) eradica-                    mon feature of much TDR-supported research. In fact,
                 tion owned by Wyeth Pharmaceuticals.                                       a conscious effort is made to conduct research in areas
     No. 82                                                                          Focus | Capacity building in Liberia


                                                          not well served by health or research facilities, so as to        ter a few hours, near Zorzor, we came up on a massive
                                                          improve access to new tools and also strengthen capacity          mud hole, a small lake. A minibus traveling in the op-
                                                          of health and research services. Still, Bolahun, as Kuesel        posite direction had become stuck in the middle. We fi-
                                                          would discover, embodied a kind of extreme.                       nally managed to pull the bus out with both of our 4x4s
                                                                                                                            hooked one to the other. But before we could go through
                                                          During the war, Bolahun had been a point of passage for
                                                                                                                            the hole ourselves, another oncoming car drove in and
                                                          rebels to and from Monrovia. Like much of the area, it had
                                                                                                                            also became stuck. We pulled that one out too, and yet
                                                          been ravaged. Schools were burned, clinics were looted
                                                                                                                            another blocked our way, and then another, and another.
                                                          and once-bountiful farmland had been abandoned. Those
                                                                                                                            We pulled one vehicle after another out without getting a
                                                          who had remained in Bolahun had endured the daily
                                                                                                                            chance to go through ourselves. By then it was dark, we
                                                          misery of life in a war zone. Yet the area’s relative isolation
                                                                                                                            were not even supposed to be on the road, and Fatorma
                                                          in postwar Liberia was precisely what recommended its
                                                                                                                            decided we should try going around the hole somehow.
                                                          election as a moxidectin trial site. Lofa County’s residents
                                                                                                                            He hooked the winch to a tree at the top of a hill by the
                                                          had not had access to annual ivermectin (Mectizan®)
                                                                                                                            side of the road and tried to drive the car up, to no avail.
                                                          treatments available in many onchocerciasis-endemic
                                                                                                                            We then considered returning to Monrovia and taking
                                                          African regions.
                                                                                                                            a helicopter the next day, but we weren’t sure we would
                                                          These treatments have dramatically reduced oncho-                 make it back in time. So we stayed put.”
                                                          cerciasis symptoms and intensity of infection over two
                                                                                                                            Four hours later, there was a break in the ‘flow’ of on-
                                                          decades. Ivermectin-naïve subjects thus represent the
                                                                                                                            coming traffic, and the WHO convoy finally powered
                                                          best test of moxidectin’s efficacy. Phase III trial find-
                                                                                                                            through. Kuesel, who had remained with the vehicle
                                                          ings here, as well as in similar communities in DRC
                                                                                                                            throughout the ordeal says, “that was quite a lesson for
                                                          and Ghana, would be of great scientific relevance (see
                                                                                                                            me. I’ll never again go in the rainy season without solid
                                                          box).
                                                                                                                            boots to wade through knee-deep mud to a ‘bathroom’.”

                                                          Getting there
20                                                                                                                          Capacity building in remote locales
                                                          In the years since the war, Bolahun has slowly begun
                                                          to recover. Yet during the dry season, the 220-kilometer          As hard as it had been to get to Bolahun, the mud was
                                                          drive from Monrovia over mostly dirt roads can take up            merely a precursor of other hurdles to be overcome be-
                                                          to 10 hours. In the rainy season, it can take twice that          fore the Phase III launch. On her very first visit to Bo-
                                                          or longer.                                                        lahun in April 2007, Kuesel had encountered a place as
                                                                                                                            devoid of infrastructure as any in which she had ever
                                                                                                                            worked. Bolahun had no public transportation, no sew-
              Map: Lisa Schwarb • Photo: WHO/TDR/Kuesel




                                                                                          Guinea
                                                                                                                            age system or sanitation, no phone service or source of
                                                           Sierra Leone                                                     electricity, and not a single concrete building.
                                                                                                                            “We didn’t realize when we planned the budget that
                                                                                                                            we would actually have to build a research centre. We
                                                                                                                            were truly starting from scratch.” When Kuesel asked
                                                                                                                            how building materials would be supplied, Bolay and
                                                                                                                             Salifu explained that sun-dried mud bricks would be
                                                                                                         Côte d’Ivoire
                                                                                                                                       produced locally. “Seeing a question about
                                                                                                                                            the durability of such a building plainly
                                                               Monrovia               Liberia                                                 written on my face, they laughed and
                                                                                                                                                pointed to the mud-brick church
                                                                                                                                                 next door,” she says. “It had been
                                                                                                                                                  there, they observed, since 1942.”
                                                                                                                                                    By the time Kuesel made her third
                                                                                                                                                   visit to Bolahun in November
                                                                                                                                                   2008, workers were putting the
                                                          Kuesel well recalls setting off from Monro-                                            finishing touches on a clinical re-
                                                          via to the village on her second visit there in                                      search centre complete with labora-
                                                          September 2007. She was traveling with three                                     tories and examination rooms, meeting
                                                          Liberian colleagues: Fatorma Bolay, disease preven-                          room and computers. The centre also includ-
                                                          tion and control officer in WHO’s Liberia office and act-         ed several “guest” quarters where, given the poor roads
                                                          ing director of the Liberian Institute for Biomedical Re-         and transport, subjects could spend the night between
                                                          search (LIBR); Henry Salifu, national coordinator of the          daily examinations required by the protocol.
                                                          health ministry’s Onchocerciasis Control Programme;
                                                                                                                            Outside were parked the three TDR-provided 4x4 ve-
                                                          and Fred Sirleaf, the study coordinator.
                                                                                                                            hicles to transport subjects and staff to villages, and two
                                                          “Our two-vehicle convoy had passed Gbarnga, where the             20-foot containers filled with equipment and consum-
                                                          paved road stops, and from there on you could hardly              ables, including 15 motorbikes to ease movement by re-
                                                          call it a road; it was more like a series of mud holes. Af-       search and health centre staff to surrounding villages.
                          Focus | Capacity building in Liberia                                                                                       No. 82




   Sites untouched by ivermectin are ideal sites for moxidectin trial
   Timing and location of the Phase III moxidectin clinical trial is critical to its success. For the study to provide
   reliable data on the safety and efficacy of moxidectin, it has to occur before the arrival of ivermectin from
   the Merck Mectizan® (ivermectin) Donation Program. Donated ivermectin has reached more than 55 mil-
   lion Africans in 34 African countries over the past two decades, largely through an innovative community-
   directed treatment strategy developed by TDR and implemented by the African Programme for Onchocer-
   ciasis Control.
   In Lofa County, however, ivermectin distribution was delayed due to the civil war, and paradoxically as a
   result, its residents are ideal candidates for the trial of moxidectin. Kuesel explains: “Ivermectin is a very
   effective microfilaricide. It kills the small worms that cause the disease symptoms (blindness, skin rash, le-
   sions) and disease transmission. However, the adult worms, which live in their human host for up to twelve
   years, continue to produce microfilaria. Therefore you have to provide for the mass distribution of ivermec-
   tin annually to residents of endemic areas in order to keep the number of microfilaria low.”
   While low microfilaria levels eliminate or prevent progression of disease symptoms, they make it very
   difficult to measure the effect of moxidectin on the macrofilaria. This explains the importance of launching
   the study of moxidectin in areas like Lofa County, before ivermectin treatment is introduced.
   From the research done so far, it appears that moxidectin is likely to be as effective a microfilaricide as
   ivermectin. “But it needs to be able kill or sterilize the adult worms, and be safe for large-scale use, to
   qualify as a potent tool for global eradication of onchocerciasis,” says Kuesel.
   Should critical Phase III trials show positive results in three years’time, that would be a big step towards
   the eradication goal – but not the final one. Larger Phase IV trials would then be initiated to ensure that the

                                                                                                                                                     21
   drug is safe and effective in mass treatment. n




(In one DRC site bicycles are being used due to inferior




                                                                                                                                    WHO/TDR/Kuesel
road conditions.) There was still a well to be dug and a
water tower to be built, but those tasks would have to
wait for the dry season.


Setting the tone and training the staff
On the day Kuesel and Elango arrived, Bolay called the
first meeting in the new clinical research centre, where
he introduced the TDR team to the Liberian study staff.
But Bolay also had to deliver an important message: “He
explained that this trial presents a unique opportunity
for the team and for Liberia. Many of the trial’s staff
members were making a sacrifice by moving to Bolahun
from Monrovia, even those who were returning ‘home’ to
this area after having fled during the war.
                                                                Study staff conducting a ‘dry run’ for discussion of the study in
“And he stressed that every team member, from driver to
                                                                community meetings.
physician, had been recruited because of their qualifica-
tions and capabilities. If they took advantage of the train-
ing, worked collaboratively, and established the right          “We wouldn’t be where we are now without him.”
work habits and attitudes, the trial would be a personal
success and a national one.”                                    After the meeting, Kuesel got to work. Along with Elan-
                                                                go, she conducted staff training sessions on the research
An expert in transmission dynamics and control of on-           protocol, on Good Clinical Practice (GCP) and Good
chocerciasis, malaria and schistosomiasis and a former          Clinical Laboratory Practice (GCLP), and on standard
TDR grantee, Bolay had stayed in his native Liberia             operating procedures (SOPs).
throughout the war, passing up higher-paying positions
in Europe and the USA to coordinate emergency health            “Conduct of clinical trials according to GCP and GCLP
action for victims of violence. If there was anyone with        ensures that data obtained are accurate, credible and com-
the poise and experience to manage a major clinical trial       parable across different trial sites,” Kuesel observed. “And
in a place like Bolahun, it was Bolay.                          GCP safeguards the well-being of subjects and respects
                                                                their rights. No matter how disadvantageous something
“Officially, he’s the institutional principal investigator on   might be for the study, if it’s better for the subject, it will
the study. But in reality, he’s so much more,” says Kuesel.     be done.”
     No. 82                                                    Focus | Capacity building in Liberia




              WHO/TDR/Kuesel




                               New clinical trial research centre stands ready for operations.


                               One of the most important aspects of GCP is the pro-              Setting up the equipment
                               cess of informing potential trial subjects about the
                                                                                                 “In selecting the equipment to be provided both to Bo-
                               study and its risks. Here too, the moxidectin research
                                                                                                 lahun and to the trial sites in DRC, we had to take their
                               presents unique challenges. In most clinical trials pa-
                                                                                                 remote locations into account,” Kuesel explains. For in-
                               tient recruitment will be a result of a routine visit to a
                                                                                                 stance, from Bolahun there is no way to get samples to
                               health centre. But people rarely seek treatment for on-
                                                                                                 a central, accredited laboratory. So the village research
22                             chocerciasis so a more proactive approach is required.
                                                                                                 centre needed a laboratory with analytical equipment
                               “The study team goes to villages in the area and holds            facilitating strict quality control and assurance.
                               community meetings in which they discuss the study                For that purpose, Kuesel had purchased some of the
                               plans with the community members,” Kuesel says.                   more sophisticated machinery on the market, “the kind
                               “They then provide those interested with further detail           that would leave minimal room for operator error.” As
                               about risks as well as benefits, alternatives, potential          a precautionary measure, Kuesel also had ordered du-
                               compensation for lost work – anything that could influ-           plicates of all critical equipment. Getting an engineer
                               ence a person’s decision to participate.”                         to fix, say, a biochemistry analyzer would be a very
                                                                                                 time-consuming and expensive endeavor in Bolahun.
                               In order to prepare for such a process, Kuesel and
                                                                                                 Moreover, were refrigerators to malfunction, even for
                               Elango simulated an informed consent meeting. “We
                                                                                                 a short period of time, the loss could have devastating
                               gathered the clinical trial staff together,” says Kuesel.
                                                                                                 consequences for the study: “so we made sure to have
                               “One person read aloud, paragraph by paragraph, from
                                                                                                 backups.” Finally, since there was neither cell phone
                               the informed consent form, and others pretended to be
                                                                                                 transmission in Bolahun nor a nearby courier service
                               members of the community, asking questions that they              (common in less remote areas of Africa), satellite-based
                               thought people would raise.                                       phones and internet had to be ordered.
                               “It was a lot of fun and it was also instructive. For in-         “We had about 80% of the equipment and consumables
                               stance, the study field assistant asked if he could bring         that we had purchased for the study and the centre
                               his children to participate in the study. He said, ‘I have        shipped to Bolahun in the two 20-foot containers,” she
                               a child of 15, a child of 15-and-a-half, and a child of           recalls. “And we spent the first two days of our Novem-
                               16...’ And I thought to myself, three children born in            ber stay in Bolahun unpacking it all.”
                               the space of a year? How is that possible?’ “But then
                                                                                                 Even so, the satellite dish for internet and phone access
                               I realized my mistake. I had forgotten that in Liberia
                                                                                                 was yet to be installed. So Kuesel had a unique way of
                               polygamy is practiced.”
                                                                                                 keeping in touch with the outside world. Together with
                               Learning to understand cultural cues is one of the                her driver, Mr Massalay, she would drive some two ki-
                               things Kuesel loves about her job. “That’s also when it           lometers out of town everyday and walk up to a hilltop
                               becomes clear how important it is that staff members              where she could capture a faint cellular phone signal.
                               are from the study area, and that everybody, including            At the pre-appointed time of 4 p.m., her colleague in
                               your field assistants and your drivers who interact with          Geneva would phone.
                               the subjects outside the ‘physician-subject’ or ‘nurse-           Yet even once the phone and internet connections, as
                               subject’ relationship, understand the study well,” she            well as other purchased hardware, are finally up and
                               says. “Local staff understand the customs and beliefs of          running this spring, the biggest barrier to a smooth
                               the communities, and they can help explain the study              successful clinical trial in Bolahun has yet to be entirely
                               to potential study subjects in a way that is meaningful.”         overcome.
                           Focus | Capacity building in Liberia                                                                                         No. 82




Powering a future                                               As the search for a donor of solar technology continues,
                                                                Kuesel has realized that in fact, what the team has been
That barrier does not involve recruiting subjects or im-        developing in Bolahun, out of practical need rather than
porting equipment or even building a clinical research          any deliberate ideology, is a field health research facility
centre out of mud bricks. In fact, the trial sites located in   that also has the potential to become a model of environ-
the Democratic Republic of Congo are in places almost           mental sustainability in the health sector.
as resource-poor as Bolahun.
                                                                “We have built the centre for clinical trials to interna-
What sets Bolahun apart, however, is the fact that the          tional standards using mostly mud-bricks manufactured
village, like much of Liberia, lacks a stable source of elec-   locally. We designed the building with features that keep
tricity and thus a reliable source of power for the equip-      the temperature in the rooms relatively low without air
ment essential to a study. “Thinking about how our              conditioning. This was a cheap yet durable method of
convoy had become stuck in the mud on the way to Bo-            construction that also has a minimal ecological ‘foot-
lahun made me shudder at the thought of having to rely          print’,” she says.
on diesel fuel generators for the research centre,” Kuesel
                                                                “We also have sought ways to dispose of the centre’s
says. “So when I suggested to Fatorma and Henry that we
                                                                health waste in a manner that is safe and sanitary, al-
try to find a fuel-independent energy source, they loved
                                                                though we would still like to go further here in terms of
the idea. They told me about Liberia’s ambitious pre-war
                                                                developing a waste disposal system that is more envi-
plans to supply all of the country’s health centres with
                                                                ronmentally friendly. For the diesel power generators, we
solar power. The war had stopped them from carrying
                                                                have explored the possibility of using scrap waste from
out the plan, but it’s still alive.
                                                                surrounding rice fields and banana plants as a source of
“By installing solar power at the centre in Bolahun, we         biofuels. And then, of course, there is our quest to de-
would not only increase the likelihood of success for this      velop solar power generation...”
trial, but we would also lower the cost of future research
                                                                On one of their first nights in Bolahun, Kuesel and
undertakings here, leveraging even greater benefit from
                                                                                                                                                        23
                                                                Elango were preparing the next day’s session when they
the investment made here in capacity building.”
                                                                saw a teenage boy carrying two chairs to the street-
In her efforts to secure solar power for the clinical trial     light newly installed for the research centre’s secu-
site, Kuesel talked to Rolf Korte, then chair of TDR’s Joint    rity. He sat down on one and placed his books on the
Coordinating Board, who put her in contact with Dieter          other, and Kuesel snapped a picture. “He was doing
Uh, alternative energy head at the German Gesellschaft          his homework,” she says with a smile. “It drove home
fuer Technische Zusammenarbeit (GTZ). Uh arranged               to me the impact a fuel-independent energy source
for Matthias Bergmann, a consultant studying renewable          would have, way beyond clinical research. I know that
energy sources in Berlin, to design a solar power system        somebody out there will want to be a part of this.”
for the Liberian site.


                                                                                                                                       WHO/TDR/Kuesel
He designed the system with three potential energy gen-
eration capacities: 1) to support only the study’s energy
needs; 2) to support expansion of the research centre,
and 3) to power the health centre and nearby Bolahun
High School. The high school, founded by monks in
1925 and further developed by the Peace Corps in the
1960s and 1970s was the pride of the northern Liberian
region prior to the war. Its graduates have included a
vice-president of Liberia, university presidents, associ-
ate supreme court justices, lawyers, nurses and doctors,
including Bolay. Recently, the school has been rebuilt
thanks to the contributions of alumni.                          Under the light of the research centre.

“It was clear from the start that the price tag for solar
power was too high for our clinical trial budget, despite       As with any drug undergoing clinical trials, there is the
the fact that it is relatively ample thanks to the Wyeth        chance that moxidectin may not succeed. Even so, the
donation,” says Kuesel. “But we were optimistic about           investment in human and infrastructure capacity will
recruiting a donation of solar panels.”                         remain. “We’re not just building capacity for this clinical
Unfortunately, the company initially approached de-             trial. We’re helping Liberia recover from war, revive its
clined to make a contribution. For the time being, the          research track and stimulate sustainable development –
clinic is running on conventional diesel generators,            and we’re starting in Bolahun.” y
while other donors are sought.                                                                            - Written by Patrick Adams
Diesel generators can’t offer peace of mind. “We lose a lot
of sleep worrying that both the generator and back-up
generator will simultaneously break down,” says Kue-
                                                                     Contact: Dr Annette Kuesel
sel. And these provide only enough energy to run the               kuesela@who.int
research centre.
     No. 82                                          Article | Research on new HAT treatment regimens


                        Clinical trials in northern Uganda

                        TDR explores shorter HAT
                        treatment options
                        TDR is conducting clinical trials for two new drug treatment regimens for human African trypanosomiasis
                        (HAT). If successful, these would significantly reduce length of treatment for both early and late stages. In
                        2008, a TDR expert team visited clinical trial sites in northern Uganda. They observed how the trials have
                        strengthened human and infrastructure capacity as well as underlining the need for greater community
                        awareness of HAT symptoms so that people can be treated early.
              WHO/TDR




24




                        Screening for HAT in Adjuman, Uganda.


                        While prevalence is generally on the decline, human Af-       stage disease, there is a potential to blunt the emergence
                        rican trypanosomiasis (HAT), or sleeping sickness, re-        of resistance to the current monotherapy treatment with
                        mains an important public health risk in many remote          eflornithine®, where an increased rate of patient relapse
                        areas of Africa, where it is endemic in 36 sub-Saharan        has been observed.
                        countries (see box: About HAT).                               For late-stage T.b. gambiense, the Uganda trials are com-
                        Yet there are a very limited number of drugs available        paring a nifurtimox+eflornithine combination with the
                        for HAT treatment. And their unwanted side effects, as        standard eflornithine regimen to see if the combination
                        well as the lack of prospects for the development of new      drug treatment can be as at least as safe and effective,
                        products, have prompted TDR-supported researchers to          while being delivered in only 10 days, as compared to the
                        examine innovative new modes of treatment using exist-        current 14-day regimen. The shortened regimen being
                        ing drugs. These include a new therapeutic drug combi-        tested also would require only two infusions daily plus
                        nation for the late stage of the T.b. gambiense form of the   oral medication, as compared to the present regimen of
                        disease as well as a shortened drug regimen for its early     four infusions. The trial involving 109 patients is due to
                        stage.                                                        finish in June, after which results will be analyzed.1

                        The two treatment regimes hold the potential to reduce        A second study, launched in February 2008, assesses a
                        unwanted side-effects of drug toxicity and to simplify        three-day course of pentamidine for early-stage HAT (t.b.
                        and lower costs of treatment. Also, in the case of late       gambiense) against the current 7-10 day regimen.2 The
                        Article | Research on new HAT treatment regimens                                                           No. 82



trial is based upon a review of pharmacokinetic informa-




                                                                                                                         WHO/TDR
tion and a preliminary study indicating that pentami-
dine has a prolonged elimination periodin the individual
treated, so a shorter regimen might be as effective while
reducing unwanted adverse effects.3,4


Late-stage gambiense disease
Study of the nifurtimox-eflornithine combination for
treatment of late-stage HAT is taking place at two clini-
cal trial sites in northern Uganda: Omugo Health Cen-
tre and Moyo District Hospital.
The two sites were selected based on their track record
as HAT treatment centres and the availability of staff
that could be trained to undertake the study. The study
is part of a broader collaborative effort with the Drugs
for Neglected Diseases initiative (DNDi) and Epicentre,
                                                            Patient in Omugo Health Centre, northern Uganda.
a Paris-based clinical studies group, to seek alternative
treatments for gambiense disease. The drugs used in
the study are donations from Sanofi-aventis (eflorni-       A shorter drug treatment course would not only vastly
thine) and Bayer AG (Nifurtimox - Lampit).                  simplify treatment and lower its costs, but it would also
                                                            lessen the risk of pentamidine accumulation in the
During the visit to Omugo, the TDR team attended a
                                                            body and related adverse effects. The trial is of particu-
formal handover to the health centre of facilities made
                                                            lar importance now in light of the fact that the only oth-
available for the trial. TDR had helped to renovate and
equip a 22-bed clinical trial ward at the centre as well
                                                            er drug candidate in the pipeline for early stage HAT,
                                                            pafuramidine (DB289), was placed on clinical hold in                   25
as a laboratory, noted the site’s principal investigator,
                                                            late 2007 by its pharmaceutical developer.6
Freddie Kansiime. With patient recruitment finished
and the study nearly completed, these facilities were       In this trial, however, recruitment of HAT patients
handed back to the health centre for routine uses. This     has been a particular challenge. Identification of HAT
illustrates how the human and infrastructure capacity       victims at early stages of the disease is often difficult,
developed for the trial will have long-lasting impacts on   and symptoms may be confused with other ailments.
health services.                                            Access to area villages, where early-stage cases of HAT
                                                            may be found, has proven to be a challenge. It is even
At the ceremony, a local member of Parliament, E
                                                            difficult for the health centres at Adjuman and Moyo
Wadri, described HAT as a major public health prob-
                                                            to communicate; even though they are quite close to-
lem in that area and emphasized the need to develop
                                                            gether, they are separated by the Nile.
new diagnostics for early diagnosis and treatment as
well as more effective drugs.                               To illustrate the complexity and high resource demands
                                                            required, Moyo’s principal investigator, Jimmy Opigo,
“HAT patients who go undiagnosed only to be treated
                                                            took the TDR team to observe a mobile screening activ-
in the late stages of the disease often suffer from per-
                                                            ity in one of the area villages. The village was in a very
manent physical, neurological, intellectual and/or men-
                                                            remote area with poor roads and difficult access. But
tal disabilities, and they may become a burden to their
                                                            upon arrival, the TDR observers found that hundreds
community,” he said.
                                                            of villagers had already been screened without a single
                                                            case of HAT being found.
Diagnosing and treating HAT                                 Although HAT certainly lurks in this region, communi-
(gambiense) in its early stages                             ties themselves are generally not aware of the signs and
                                                            symptoms, and therefore fail to seek treatment early. To
In Moyo and Adjuman, another remote Nile River vil-
                                                            support this observation, Dr Opar of Adjuman’s hospital
lage in northern Uganda, a clinical trial of a three-day
                                                            talked of a divorced patient who had been abandoned
course of pentamidine for early-stage HAT is also under
                                                            by her family and declared as either suffering from HIV
way.
                                                            or mental illness. When the patient went to the hospi-
Launched in February 2008, the trial is examining           tal, she was diagnosed with very late-stage HAT and
whether the current 7-10 day regimen of daily intra-        was under treatment at the time of the team’s visit. The
muscular injections with pentamidine could be re-           doctor promised to step up the sleeping sickness aware-
duced to just three days.5 The shorter course is based on   ness campaign to ensure that patients seek treatment
pharmacokinetic evidence indicating that pentamidine        early and avoid the complications of late-stage disease
has a prolonged elimination period; the drug remains        and its consequences. It was also observed that lack of
at therapeutic levels in the body for over 29 hours after   awareness may account for the slow rate of recruitment
a single IV administration.                                 into the study. Some 80 patients have been recruited,
                                                            while the target is 200.
     No. 82                                          Article | Research on new HAT treatment regimens




              WHO/TDR
                                                                                                       About HAT
                                                                                                       Transmitted by tsetse flies, HAT occurs in
                                                                                                       two forms: a generally acute form caused by
                                                                                                       Trypanosoma brucei rhodesiense and a usually
                                                                                                       chronic form caused by Trypanosoma brucei
                                                                                                       gambiense. Each form of the disease presents
                                                                                                       as Stage 1 (also called early or haemolymphatic
                                                                                                       stage) or Stage 2 (late stage or meningo-en-
                                                                                                       cephalitic phase).
                        Handover of improved health-care facilities to Omugo Health Centre
                        following HAT trial completion.                                                Uganda is the only endemic country where
                                                                                                       both the acute form and the chronic disease
                                                                                                       coexist. T.b. rhodesiense is endemic in the south,
                        Rhodesiense HAT endemic in south                                               while T.b. gambiense is endemic to the north.
                        migrates towards gambiense zone                                                                               The treatment of




                                                                                             WHO/TDR
                        While new drug treatments for the gambiense form                                                              HAT is depen-
                        of HAT are sought, another trend is causing concern:                                                          dent on the form
                        the possibility of an intermingling between the T. b.                                                         and stage of the
                        gambiense species endemic in the north and T. b. rho-                                                         disease: early
                        desiense, which is endemic in the south but appears to                                                        stage gambiense
                        be migrating slowly northward, largely due to the un-                                                         disease is treated
                        checked movement of cattle.7                                                                                  with pentami-
                                                                                                       dine and late stage with eflornithine or melar-
26
                        In order to discuss this issue, the TDR team also visited                      soprol; while early stage rhodesiense disease
                        the Namungalwe Health Centre in southern Uganda.                               is treated with suramin and late-stage with
                        There, Dr Kakembo, director of the National Sleeping                           melarsoprol.
                        Sickness Control Programme, and his deputy Dr Wam-
                        boga, described how the health centre, which functions                         Although molecular methods are available that
                        as a referral centre for patients with sleeping sickness,                      can distinguish between the two species,8 diag-
                        was built to treat patients during the last large T. b.                        nostic tools routinely used in the field cannot.
                        rhodesiense epidemic in the 1980s.                                             As a result, mingling of the two parasite species
                                                                                                       in the same geographic locale would create a
                        He also explained that Uganda is the only country in Af-                       difficult situation for making decisions regard-
                        rica where both T. b. rhodesiense and T. b. gambiense co-                      ing treatment options. n
                        exist. The intermingling of the two species in the same
                        geographic region, however, could greatly complicate
                        diagnosis and treatment. If the two diseases converge,
                        a drug treatment effective against the two forms would
                        be required. Potentially, the usefulness of a nifurtimox
                        + eflornithine combination could be examined in a site
                        such as Namungalwe.                                                  1     “Clinical study comparing the nifurtimox-eflornithine combination
                                                                                                   with the standard eflornithine regimen for the treatment of
                        Kakembo also observed that while prevalence of the                         trypanosoma brucei gambiense human African trypanosomiasis in
                        rhodesiense form of HAT that is common in the south                        the meningo-encephalitic phase”: ISRCTN03148609 (see http://www.
                        appears to have declined markedly, this also could                         controlled-trials.com/ISRCTN03148609)

                        partly be due to lack of active screening and mobili-                2     “Assessing three-day pentamidine for early-stage human African
                                                                                                   trypanosomiasis”: ISRCTN35617647 (see http://www.controlled-trials.
                        zation of communities. This underlines again the need
                                                                                                   com/ISRCTN35617647)
                        to stimulate grassroots awareness of the symptoms of
                                                                                             3     Expert group meeting, 14-15 April 2004, WHO/TDR.
                        early-stage HAT to facilitate treatment that can lead to
                                                                                             4     Priotto et al. Clinical Infectious Diseases 2007;45:1443–1445
                        a full recovery.
                                                                                             5     ISRCTN35617647
                        Along with testing new drug combinations, the TDR                    6 Immtech Pharmaceuticals. Script No 3340, p 22, February 2008
                        trials have helped improve the skill levels of the col-              7 Févre EM et al. A burgeoning epidemic of sleeping sickness in Uganda.
                        laborating medical teams, stimulating them to think                    Lancet 2005; 366(9487):745-747
                        about needs for such improved outreach and diagnosis                 8 Picozzi K et al. Sleeping sickness in Uganda: a thin line between two
                        of HAT in remote areas, according to Deborah Kioy, the                 fatal diseases. British Medical Journal 2005 November 26; 331(7527):
                        TDR scientist who has been managing the drug trials.                   1238–1241. Available from: http://www.pubmedcentral.nih.gov/
                        However, there needs to be further follow-up by con-                   articlerender.fcgi?tool=pmcentrez&artid=1289320

                        trol officials at country level, and in coordination with
                        WHO, to ensure that activities instituted for the studies
                        continue following their conclusion. y                                        Contact: Dr Deborah Kioy
                                                                                                   kioyd@who.int
                                       - With reporting from Deborah Kioy in Uganda
                           Meetings | Stewardship • Environment and agriculture                                                         No. 82




Stewardship’s Strategic Advisory Committee meets
TDR’s newest area of work – the Steward-    Infectious Diseases, initiated its activities   Stewardship is also developing a high-
ship function – held a second Strategic     in October 2008, and will be developing         level advocacy group to help communi-
and Scientific Advisory Committee (SAC)     its first annual report in late 2009. That      cate recommendations emerging from
meeting 12-14 January. One of Steward-      group has already developed a struc-            the global report. The SAC co-chaired by
ship’s key products is the new global       ture for its activities that the SAC recom-     professor Eyitayo Lambo, former minister
report on infectious diseases research.     mended as a model for the nine other            of health of Nigeria and Gillian Samuel,
This is a major new undertaking planned     reference groups being established as           president of the Foundation Council,
for draft review by the end of 2010. The    part of the initiative. The annual reports      Global Forum for Health Research, rec-
report sets out to highlight the top re-    of the reference groups will be consoli-        ommended that the high-level advocacy
search priorities among infectious dis-     dated as a technical document that will         group be developed in partnership with
eases of poverty that can assist policy     be used to produce a top level overview         other organizations. Possible categories
makers, researchers, funders and other      of challenges, opportunities and research       of members include ministers of health,
stakeholders. In the recent SAC meet-       priorities in infectious diseases by a “think   science and technology, education, opin-
ing, committee members discussed the        tank” with cross-cutting activities and har-    ion leaders and philanthropists. y
initiatives under way that would con-       monized approaches. The think tank will
tribute to this report. These range from    include representatives from the refer-
the 10 new disease and thematic refer-      ence groups. The SAC also recommended
ence groups being established by TDR’s      inviting people from outside the scientific
Stewardship function to examine global      groups with diverse backgrounds who                For more information on SAC membership
research gaps and needs in specific ar-     can help identify fresh ideas and ap-              and a list of the disease-specific and
eas, to the expansion of TropIKA.net as a                                                      thematic reference groups, visit:

                                                                                                                                        27
                                            proaches to framing the challenges iden-
‘one stop shop’ platform for research on                                                       www.who.int/tdr/svc/stewardship
                                            tified by each of the reference groups in
infectious diseases of poverty.
                                            a global context – including socioeco-
                                                                                                 Contact: Dr Ayoade MJ Oduola
The first such thematic reference group     nomic, political, national and regional
                                                                                               oduolaa@who.int
(TRG), on Environment, Agriculture and      perspectives.




Environment, Agriculture and Infectious Diseases
Thematic Reference Group launches activities
Changes in global environmental and         in 2009 and 2010 as part of its Steward-        While the group will focus on global
agricultural systems are among the          ship function for infectious diseases of        issues and trends, its outputs are also
major overlooked factors in the persis-     poverty. The TRG/DRGs aim to evaluate           expected to address public health chal-
tence, emergence and re-emergence of                                                        lenges in China. “Collaborations with
                                            and synthesize scientific information on
infectious diseases. These also interact
                                            specific global health issues, providing        Chinese research institutions and China-
with trends of economic development,
population growth, urbanization, mi-        guidance on priority research gaps and          based international agencies will be of
gration and pollution. Climate change       needs that should be addressed.                 critical importance to the expert group’s
and variability add new factors to this                                                     analysis and findings,” says Johannes
conglomerate of driving forces, as do       Appearing at the Beijing meeting, Ayo-          Sommerfeld, TDR manager of the refer-
related trends of over- and under-nu-       ade MJ Oduola, TDR’s Stewardship leader,        ence group.
trition.                                    stressed that the new China-based effort
                                            reflects TDR’s increasing commitment to
                                                                                            Stakeholder consultation paves
                                            addressing how global environmental
These are among the issues to be ad-                                                        way for meeting
dressed by a new Thematic Reference         change, including climate change, im-
                                            pacts the epidemiology and control of           A stakeholders’ consultation convened
Group (TRG) of international experts
                                            infectious diseases of poverty.                 in Beijing on 21 October to discuss the
on Environment, Agriculture and In-
                                                                                            planned framework for the TRG’s activi-
fectious Diseases (TRG-4), which held       He noted that the expert group will be          ties. The consultation, co-organized by
its first meeting 22-23 October 2008 in     based in China for a minimum of four            the WHO Representative Office in China,
Beijing, China.                             years (2008-2012). It will operate in col-      TDR and the Chinese Center for Disease
The expert group is one of 10 such the-     laboration with the WHO Representative          Control and Prevention (China CDC),
matic and disease-specific reference        Office in China and with approval of the        brought together Chinese health offi-
groups efforts being launched by TDR        Chinese Ministry of Health.                     cials and regional representatives of in-
     No. 82                                     Meetings | Environment and agriculture




       Thematic Reference Group on Environment, Agriculture and Infectious Diseases: stakeholder consultation and meeting in Beijing.


       ternational agencies. Presentations were              tute of Parasitic Diseases in Shanghai,                   Members of the Thematic Reference
       made by the China Council for Interna-                also discussed trends related to climate                  Group (TRG)
       tional Cooperation on Environment and                 change and agriculture with Lin Erda                      Dr Anthony McMichael, TRG chairperson,
                                                                                                                       National Centre for Epidemiology and Popula-
       Development and the United Nations                    of the Chinese Academy of Agricultural                    tion Health, The Australian National University,
       Food and Agriculture Organization. Chris              Sciences.                                                 Canberra, Australia.

       Tunon described WHO activities on be-                                                                           Dr Xiao-Nong Zhou, TRG co-chair, CDC National
                                                             Although China has made significant                       Institute of Parasitic Diseases in Shanghai, China.
       half of the WHO Representative in China.
                                                             progress in combating infectious diseas-                  Dr Corey Bradshaw, Research Institute for
                                                                                                                       Climate Change & Sustainability, School of Earth
       Stakeholders stressed the need for pro-               es, many persist and re-emerge, noted                     & Environmental Sciences, University of Adelaide,
       spective, systemic and ecological ap-                 Kai JianLi director, Office for Epidemiol-                Australia.


28
       proaches to the issues. Interdisciplinary             ogy, China CDC. Public health challeng-                   Dr Stuart Gillespie, Agriculture and Health
                                                                                                                       Research Platform, International Food Policy
       and inter-sectoral research are needed                es include dysentery, gonorrhea, viral                    Research Institute (IFPRI), Geneva, Switzerland
       to address complex linkages that exist                hepatitis, HIV/AIDS, malaria, measles,                    Dr Felipe Guhl, Centro de Investigaciones en
       between environments, agriculture and                 schistosomiasis, syphilis, tuberculosis                   Microbiologia y Parrasitologia Tropical - CIMPAT,
                                                                                                                       Bogota, Colombia.
       infectious diseases, and those linkages               and typhoid and paratyphoid fevers.                       Dr Anthony Okon Nyong, Agriculture and
       to poverty. TRG analysis and recommen-                Emerging diseases include SARS (2003),                    Agro-Industries Department, Environment and
       dations should be expressed in practical                                                                        Natural Resources Division, African Development
                                                             avian influenza (2004), angiostrongyli-                   Bank, Tunis Belvedere, Tunisia.
       terms relevant to policy-makers’ actions.             asis (2006) and EV71 (2008).                              Dr Suad M Sulaiman, Environment Advisor,
                                                                                                                       Khartoum, Sudan.
       The expert meeting featured overview
                                                                                                                       Dr James A Trostle, Anthropology Department,
       presentations on how environmental                    Why China?                                                Trinity College, Hartford, USA.
       change, climate change, agriculture, food             As China is undergoing rapid eco-                         Dr Jürg Utzinger, Department of Public Health
       security and disease prevalence/trans-                                                                          and Epidemiology, Swiss Tropical Institute, Basel,
                                                             nomic, agricultural and environmental                     Switzerland.
       mission interrelate. Discussion also fo-              changes, it is well placed to harness                     Dr Bruce Wilcox, Center for Infectious Disease
       cused on the need to also consider pov-               the TRG’s findings to challenges of in-                   Ecology, Asia-Pacific Institute for Tropical Medi-
                                                                                                                       cine and Infectious Disease, John A. Burns School
       erty linkages and economic systems that               fectious diseases of poverty, observed                    of Medicine, University of Hawai’i, Honolulu, USA.
       better incorporate relevant “externalities.”          Zhou, an internationally recognized ex-                   Dr A Lee Willingham III, WHO/FAO Collaborat-
                                                                                                                       ing Center for Parasitic Zoonose, Faculty of Life
       Chairperson Anthony McMichael, an Aus-                pert on schistosomiasis, a disease with                   Sciences, University of Copenhagen, Frederiks-
       tralian National University professor, de-            multiple environmental dimensions.                        berg C, Denmark.

       scribed some of the environmental and                 China has recently been challenged by                     Dr Yang Guojing, Jiangsu Institute of Parasitic
                                                                                                                       Diseases, Wuxi, China.
       agricultural factors enhancing infectious             both human-caused and natural envi-
       disease emergence and spread, includ-                 ronmental changes, including flooding                      Related resources:
       ing intensified livestock production, live            and drought as well as the 2008 Sichuan                    WHO Department for Public Health
       animal retail markets, changes to ecosys-             Province earthquake. Climate change                        and Environment (PHE)
                                                                                                                        http://www.who.int/phe/en/
       tems (e.g. dam construction, deforesta-               impacts on agricultural productivity and
                                                             vector-borne disease transmission also                     WHO/UNEP Health and Environment
       tion) and global climate change. “Often
                                                                                                                        Linkage Initiative
       factors act in concert in changing the                are of concern.                                            http://www.who.int/heli/en/
       range, seasonality and intensity of in-                                                                          IFPRI Agriculture and Health Research
                                                             Earlier in October, McMichael also
       fectious diseases transmission,” he said.                                                                        Platform
                                                             chaired a meeting of experts on climate
       “Climate change, for example, is amplify-                                                                        http://www.ifpri.org/ahrp/ahrp.asp
                                                             change and public health convened by
       ing environmental stresses from human                                                                            * WHO Expert Meeting on Climate Change
                                                             the WHO and hosted by Spain’s Ministry                     and Public Health
       pressures on water systems, land cover
                                                             of Health. The meeting, 6-8 October in                     http://www.who.int/phe/climate/
       and displacement of reservoir host spe-                                                                          meeting_madrid/en/index.html
                                                             Madrid, agreed on a research agenda to
       cies.”
                                                             develop an evidence-based framework
                                                                                                                          Contact: Dr Johannes Sommerfeld
       Co-chairperson Xiao-Nong Zhou, a pro-                 for action on the human health implica-
                                                                                                                        sommerfeldj@who.int
       fessor at the China CDC’s National Insti-             tions of climate change*. y
                                     Meetings | Empowerment • ANDI                                                                         No. 82




Empowerment SAC reviews ‘centres of excellence’
At least ten health research institutes are    Research: New funding should be sought         and research leaders as well as centres of
to be designated centres of excellence in      to support research empowerment                excellence.
infectious diseases research as a result of    grants to scientists and institutions, par-
                                                                                              Quality management: SAC commended
TDR’s Empowerment function (BL2) ac-           ticularly in small, poor countries that have
                                                                                              the progress made by Empowerment
tivities.                                      a high disease burden. More emphasis
                                                                                              on developing programmes for Qual-
                                               should be given to translation of research
Empowerment’s Strategic and Scientific                                                        ity Management training, coordination
                                               results into policies and practices, includ-
Advisory Committee (SAC) endorsed                                                             and institutional recognition in 2008. As
                                               ing strategies for publications and pack-
the plans in a meeting, 6-7 November                                                          of 2009, quality management activities
                                               aging of results for various audiences.
2008 in Geneva. The SAC also urged                                                            are to be transferred to TDR’s team on
that TDR will develop criteria for the         Training: Significant progress had been        Neglected Research Priorities, operating
selection of candidate centres of excel-       made on harmonization and standardiza-         there as an independent function. This is
lence, as well as indicators to determine      tion of short courses and development          to ensure that quality management cuts
if centres meet research excellence            of indicators and mentorship systems           across all TDR health research and train-
goals. TDR also plans to develop cross-        for TDR’s new stepwise programme of            ing activities. Links between TDR’s qual-
cutting indicators measuring progress          leadership training including: Leadership      ity management activities and those of
on the broader strategic goal of having        Training Grants, Leadership Development        internationally recognized accreditation
“disease-endemic countries play a piv-         Fellows and Career Development Fellows.        programmes also are being deepened
otal global role in research on infectious                                                    and developed. y
                                               Networks: Progress also was made on de-
diseases of poverty.”
                                               velopment of a data base of previous TDR
In terms of other specific Empowerment         grantees. SAC encouraged TDR to further
activities supporting research, training,      explore how its range of networks could
                                                                                                 Contact: Dr Glenn Laverack
                                                                                                                                           29
networks and quality management, SAC           be harnessed to support training, men-         laverackg@who.int
recommended the following:                     torship and grooming health researchers




ANDI Task Force plans follow-up to Abuja launch
A Task Force of the new African Network        Funding: e.g. encourage African gov-           WHO/AFRO regional office in Brazzaville,
for Drugs and Diagnostics Innovation           ernments to support R&D; provide the           Democratic Republic of Congo, 3-4 Au-
(ANDI), held its first meeting on 10 Feb-      platform for African product R&D fund-         gust. A second stakeholders meeting
ruary to plan concrete actions for turn-       ing and investment; promote establish-         is scheduled for the week of 5 October
ing the R&D initiative into a reality. This    ment of venture capitalists that focus on      2009 in Cape Town, South Africa, where
follows the launch of ANDI in October          health innovations; establish and man-         the Task Force final report will be pre-
2008 at a stakeholders’ meeting in Abuja,      age an African Innovation Fund.                sented.
Nigeria.
                                               Advocacy for product R&D at all levels:        The first ANDI stakeholders’ meeting and
The ANDI Task Force is charged with            e.g. advocate for increased investment         launch of the initiative in October 2008
developing a strategic blueprint and           in product R&D by various stakeholders         drew over 200 participants from Africa
business plan for the network. Meeting         including African governments, phil-           and around the world, including health
in Geneva, the group reviewed the po-          anthropic agencies, and international/         ministers and private sector and inter-
tential scope of ANDI’s work, options for      development bodies; establish a mecha-         governmental organization representa-
organizational structure and selection         nism to take African traditional medicines     tives.
criteria for African countries interested in   to international market standards; seek
                                                                                              ANDI aims to promote African-led R&D
hosting the secretariat.                       recognition of diagnostics/drugs registra-
                                                                                              innovation, and to support capacity and
                                               tion among African member states.
The proposed scope of work for ANDI                                                           infrastructure development, accord-
include activities related to:                 Task Force participants agreed to recruit      ing to Solomon Nwaka, TDR’s leader of
                                               a consultant to aid in developing a five-      drug discovery and innovation. It follows
Product R&D coordination and man-
                                               year strategic and business plan. The          upon WHO’s recent approval of a Glob-
agement: e.g. a framework for scientific
                                               group scheduled two more meetings, as          al strategy and plan of action on public
coordination and R&D priority-setting;
                                               well as teleconferences, in order to pre-      health, innovation and intellectual prop-
collaboration with regional and western
                                               pare for delivery of a business plan in the    erty (WHA 61.21). y
partners; management of intellectual
                                               fourth quarter of 2009.
property to protect local knowledge and
                                                                                                Contact: Dr Solomon Nwaka
promote innovation; and linkages of in-        Those will be at the African Devel-            nwakas@who.int
vestors with entrepreneurs.                    opment Bank in Tunis, 7-8 May, and the
     No. 82                               Meetings | PCR for Chagas • ASTMH


       Standardized protocol for PCR analysis of Chagas disease
                                                     setting and establishing the limitations of        the course of that week allowed for the
                                                     PCR technology as a diagnostic tool.               establishment of a standard operating
                                                                                                        procedure (SOP) for the use of PCR as a
                                                     While PCR has been employed for clini-
                                                                                                        diagnostic tool.
                                                     cal diagnosis and assessment of T. cruzi
                                                     infection for more than a decade, there            “In the absence of a validated commer-
                                                     exist numerous and widely varying labo-            cial product, we have this,” says Janis
                                                     ratory protocols for its use. The effect has       Lazdins-Helds, TDR’s leader of research
                                                     been to render unreliable comparisons              on drug development for helminth and
                                                     of PCR-based findings between groups,              other neglected diseases and one of the
       A workshop and symposium on the use           thereby slowing the pace of research.              Buenos Aires workshop’s planners. “It has
       of polymerase chain reaction (PCR) for                                                           to be made in one’s own laboratory, but
                                                     Recognizing the need for a standard PCR            it’s a start. And it’s a wonderful example
       T. cruzi DNA detection has resulted in a
                                                     protocol for T. cruzi DNA detection, a             of how basic biomedical research find-
       single standardized protocol for PCR-
                                                     consortium of researchers from Brazil, Co-         ings can be used clinically for the benefit
       based clinical analysis of the disease.
                                                     lombia and Argentina drafted a project             of both practitioners and patients.”
       Sponsored by TDR, INGEBI-Conicet UBA          proposal in 2007 and sought TDR sup-
                                                                                                        According to INGEBI-Conicet’s Alejandro
       and the United Nations University’s BIO-      port. Months later, the research began.
                                                                                                        Schijman, the initiative’s coordinator, the
       LAC programme, the workshop involved          Blinded blood samples with a known
                                                                                                        new SOP can serve as a point of refer-
       32 biomedical researchers and medical         number of parasites, purified DNA from
                                                                                                        ence not only for medical practitioners
       practitioners from 14 countries – whose       T. cruzi strains of different lineages and         interested in disease diagnosis but also
30     convening in a single forum also repre-
       sented a significant achievement.
                                                     relevant controls were prepared by the
                                                     coordinating center and sent to 29 par-
                                                                                                        for clinical researchers using PCR to eval-
                                                                                                        uate new therapies for Chagas in clinical
                                                     ticipating laboratories.                           studies. y
       Most of the participants at the meeting,
       17-22 November 2008 in Buenos Aires, Ar-      Those laboratories that achieved a mini-
       gentina, were from Latin America where        mum of concordance with the blood
       Chagas remains endemic. Over four days,       samples were invited to participate in
                                                                                                           Contact: Dr Janis Lazdins-Helds
       the group defined PCR best practices,         the workshop and symposium in Bue-
                                                                                                        lazdinsj@who.int
       outlining their applicability in a clinical   nos Aires. The information gathered over




       Rectal artesunate session draws big turnout at American
       Society of Tropical Medicine and Hygiene (ASTMH)
       Tropical medicine experts discussed re-
                                                                                                                                                      Emran Bin Yunus


       sults of randomized controlled trials of
       a life-saving, one-dose regime in rural
       African and Asian communities. The
       57th annual meeting of ASTMH in New
       Orleans also covered logistics, ethics,
       adherence to referral advice and clini-
       cal research practices.

       A rectal application of an inexpensive
       drug could save lives of patients with
       severe malaria in some of the remotest
       locations of rural Africa and Asia.

       A TDR-supported study promoting the
       treatment, Use of rectal artesunate at the
       community level in African rural settings,
       was presented to a packed session at
       the 57th American Society of Tropical
       Medicine and Hygiene (ASTMH) annual
       meeting in New Orleans, USA, 7-11 De-
       cember 2008.                                  Some Study 13 and Study 18 team members at the ASTMH.
                               Meetings | ASTMH                                                                                                    No. 82



Researchers from all over the world
gathered to hear the conclusions from a             Other TDR sessions at ASTMH
panel including TDR coordinator of the
research Melba Gomes and researchers                TDR sponsored a total of five major symposium sessions, several
Emran Bin Yunus from Bangladesh, John               papers and posters on malaria, and a presentation on TDR’s
Gyapong from Ghana, Marian Warsame                  Helminth Drug Initiative at the 57th ASTMH meeting in New
from Tanzania, and Tom Peto, Rita Baiden            Orleans. In addition to the session detailed above, TDR’s major
and other colleagues from the Study 13              sessions discussed:
Research Group.                                     • Accelerating the development and deployment of diagnostic tools
That same morning, The Lancet published             into the developing world: promises and challenges. Due to the lack
the study online.1 Lorenz von Seidlein              of laboratory capacity in the developing world, high-quality diagnos-
and Jacqueline L Deen also wrote in a               tic tests for infectious diseases are neither affordable nor accessible
                                                    to the majority of patients. Moreover, owing to the lax regulatory
commentary there, “If there are a handful
                                                    oversight of diagnostics, those tests that are available are often sold
of important papers every decade that
                                                    and used with little evidence of their effectiveness. This symposium
will influence the way malaria is treated,
                                                    described the path from diagnostic target discovery to test develop-
this study is one of them.”                         ment and deployment, identifying challenges and opportunities
That same enthusiasm was evident at the             along the way.
ASTMH session, which drew supportive                TDR contact: Dr Rosanna Peeling, peelingr@who.int
comments and questions about how to
move forward with the results.
                                                    Use of fluorescent probes and transgenic parasites to enhance drug
The study sought to determine in very               screening. This symposium highlighted progress made by a network
remote settings whether rectal arte-                of investigators from disease-endemic and non-endemic countries
sunate plus referral to a clinic reduced            using new genomic technology for drug screening.                                               31
mortality and permanent disability                  TDR contact: Dr Ayoade MJ Oduola, oduolaa@who.int
compared with rectal placebo plus re-
ferral. The multi-country study included
                                                    Home Management of Malaria (HMM) in 2008: Improving access to
over 17 000 patients, and showed that
                                                    aCTs and diagnostics at the community level in sub-saharan africa.
a single dose given rectally can be safe
                                                    This session provided a summary of how HMM is incorporating new
and effective as an initial treatment for           tools like artemisinin-based combination therapy (ACT) and rapid
patients with severe malaria who are                diagnostic tests (RDT) for malaria and addressing new challenges
too sick to take medication by mouth,               posed by communities in urban settings and integrated disease man-
and who do not have immediate ac-                   agement. See also: http://www.who.int/tdr/research/antimalarial-
cess to an injectable treatment. Rectal             policy-access/ppt/HMM-antwerp-apr08.ppt
artesunate is administered at a rural
                                                    TDR contact: Dr Franco Pagnoni, pagnonif@who.int
health centre or by a trained commu-
nity member or caregiver in order to
“buy time” while the patient is referred            Measurement and prediction of malaria treatment outcomes: Para-
for definitive treatment.                           site, drug and host factors. Leading experts reviewed the protocols
                                                    for in vitro and molecular measurements of antimalarial drug resis-
                                                    tance, their limitations, and how these relate to treatment outcomes
What is new?
                                                    TDR contact: Dr Olumide Ogundahunsi, ogundahunsio@who.int. n
The trial was the first randomized-con-
trolled study to assess the value of rectal
artesunate in community-based settings
in remote rural areas. It was undertaken
                                               The study noted remarkably high com-       1	   MF	Gomes,	MA	Faiz,	JO	Gyapong,	M	Warsame	et	
in malaria-endemic areas of Bangladesh,
                                                                                               al	from	the	Study	13	Research	Group.	The Lancet,	
Ghana and the United Republic of Tan-          pliance with the advice to go immedi-           373:557-566.

zania.                                         ately to a clinic, partly because there
                                               was a recruiter in each village and com-
In their Lancet commentary, Seidlein and
                                               munities received sustained malaria
Deen said that the trial results provide
                                               education. Before the study began in              For more information and The Lancet
“a strategy for patients with severe ma-
                                               each village, the process was explained           article, see www.who.int/tdr/svc/news-
laria who cannot access parenteral drugs                                                         events/news/rectal-artesunate-lancet
quickly.” The survival benefit is signifi-     to leaders, traditional healers and the
                                                                                                 For archives of ASTMH meetings, see:
cant in the communities where travel to        community. The trials were approved               www.astmh.org

get care takes at least six hours. Mortality   by WHO and national ethics committees
                                               and reviewed by an independent data                 Contact: Dr Melba Gomes
was halved in longer travel, a particularly
                                                                                                 gomesm@who.int
acute problem in Africa.                       monitoring committee. y
     No. 82                                                 Meetings | DEEP • Innovative vector control in Mali


                       DEEP discusses costs of ineffective diagnostics
                       The fifth annual meeting of the Diag-           line on accessible quality-assured diag-      (STIs), to estimate the costs/benefits of
                       nostics Evaluation Expert Panel (DEEP)          nostics, results from work on the human       poor quality/improved diagnostics, in-
                       3-4 November 2008 offered TDR scien-            and economic costs of low-quality diag-       cluding tests for drug resistance; the en-
                       tists a chance to engage potential col-         nostics could generate advocacy materi-       couragement of regulatory authorities
                       laborators in estimating the human and          als about their consequences.                 to work with health ministry and control
                       economic costs of low-quality diagnos-                                                        programmes; the establishment by TDR
                                                                       The meeting in Geneva opened with
                       tics for infectious diseases.                                                                 of a session on diagnostics regulation at
                                                                       an overview of the global diagnostics
                                                                                                                     the annual International Conference for
                       Owing to the lack of regulatory oversight       landscape and the process by which di-
                                                                                                                     Drug Regulatory Authorities (ICDRA); and
                       in the developing world, many diagnos-          agnostics are regulated and approved in
                                                                                                                     greater collaboration with partner organi-
                       tics are sold and used without evidence         South Africa, Thailand, the United States
                                                                                                                     zations in advocacy efforts.
                       of effectiveness. There is usually little in-   of America and India. Speaking on behalf
                       formation available on test performance.        of the European Diagnostics Manufac-          A website devoted to diagnostic tests for
                       As a result, cost is often the overriding       turers Association (EDMA), Jean-François      priority diseases was also proposed as an
                       consideration in test procurement. This         de Lavison stressed the need for inter-       effective means of disseminating infor-
                       situation has led to the marketing of           national cooperation in the regulation of     mation to health authorities, funders and
                       cheap tests with low performance char-          diagnostic tests. He called for the estab-    the public. The website would include in-
                       acteristics, which has in turn discouraged      lishment of an International Diagnostics      formation on product evaluation, includ-
                       reputable manufacturers of high-quality         Manufacturers’ Association to comprise        ing unpublished evaluations by WHO,
                       diagnostics from competing in these             companies from developed and devel-           FIND and FDA, among others, and tool
                       markets.                                        oping countries.                              kits describing how to evaluate diagnos-

32
                                                                                                                     tic tests. y
                       Assembled in 2004, DEEP has a mandate           Advocacy recommendations included
                       to advise TDR and the Foundation for In-        the use of case studies of problems or
                       novative New Diagnostics (FIND) on rec-         benefits associated with poor-quality or
                       ommendations for best practices in di-          improved diagnostics; the use of math-
                                                                                                                       Contact: Dr Rosanna Peeling
                       agnostic trials. According to TDR scientist     ematical models, such as those currently      peelingr@who.int
                       Rosanna Peeling, leader of TDR’s business       used for sexually transmitted infections



                       Biosafety course in vector control launched in Mali
                                                                                                                     to develop material for further biosafety
     Olivier Asselin




                                                                                                                     training and assessment of GM research
                                                                                                                     in Africa, Latin America and Asia. That was
                                                                                                                     followed by a TDR-supported “train the
                                                                                                                     trainers” course on laboratory biosafety
                                                                                                                     and biosecurity, 3-8 December, aimed to
                                                                                                                     consolidate and expand the initiative in
                                                                                                                     Africa, Asia and Latin America.

                                                                                                                     Standing on an open concrete terrace at
                                                                                                                     the University of Bamako on a break from
                                                                                                                     the first African training course, Couliba-
                                                                                                                     ly described how his PhD studies had
                       The year was 2002, the setting was Notre        Now, Coulibaly believes, that dialogue is     stimulated questions that he and other
                       Dame University in the USA, and a young         advancing, thanks partly to several new       researchers now seek to address more
                       Malian PhD student named Mamadou                initiatives by WHO and TDR.                   systematically.
                       Coulibaly was engaged in research re-
                                                                       Coulibaly was a member of the first TDR-      “I have a lot of theoretical knowledge in
                       lated to the genetic modification (GM)          supported course for Africa on Biosafety      the technology,” Coulibaly said, “but the
                       of mosquitoes.                                  for human health and the environment,
                                                                                                                     most interesting thing to me is: what do
                       As he considered both the potential of          17-28 November 2008 at the University of
                                                                                                                     countries and ethics boards think about
                       such research to fight disease and also         Bamako, Mali.
                                                                                                                     the release of transgenic mosquitoes into
                       the social and environmental issues it          On 29 November - 2 December, coor-            nature? How do neighbouring countries
                       inevitably raised, Coulibaly recalls asking     dinators of three new TDR-supported           interconnect with each other? And what
                       his professor and mentor, “Isn’t it better      biosafety training centres in Africa, Latin   is the response of communities where
                       to start talking about ethics issues now?”      America and Asia also met in Bamako           GM deployment is planned?
                                   Meetings | Home management of malaria                                                                                   No. 82



“We, the scientists, as well as policy-mak-             tion [AFBSA: www.afbsa.org]. “I applied            train-the-trainers course on laboratory
ers and the public, need to be assured                  for this course because I wanted to learn          biosafety and bio-security, 3-8 Decem-
that the genes we’ll be putting into mos-               more about GM insect vectors and about             ber, was organized by the Biorisk Re-
quitoes are not going to have negative ef-              laboratory safety. I want to be able to re-        duction for Dangerous Pathogens unit
fects on other organisms or on communi-                 view and evaluate proposals coming to              of WHO’s Department of Epidemic and
ties and their environment.”                            me within my institution. I want to net-           Pandemic Alert and Response (EPR). It
                                                        work and grow my association.”                     involved 11 participants from Africa,
The biosafety training course, at the Uni-
                                                                                                           Latin America and Asia, and took place
versity’s new TDR-supported Regional                    The second event , a meeting of coordi-            at the same University of Bamako Fac-
Biosafety Training Centre, was organized                nators of the three new TDR-supported              ulty of Sciences and Technology venue
by Dr Madama Bouaré of the Faculty of                   biosafety centres in Africa, Asia and Latin        as the African biosafety course.
Sciences and Technologies. The course                   America, discussed long-term plans
involved 20 participants from 11 Afri-                  for development of courses and good                These meetings pave the way for ex-
can countries. Similar courses are set for              practice guidance in ethical review and            panding biosafety training courses from
soon-to-be-opened regional centres in                                                                      Africa to Asia and Latin America over the
                                                        risk assessment of GM research/deploy-
Asia and Latin America in 2009.                                                                            coming three years. Researchers such
                                                        ment. Meeting participants also included
                                                                                                           as Coulibaly from around the world will
Willy Kiprotich Tonui was another bio-                  the investigators involved in a TDR proj-
                                                                                                           thus be able to delve into the ethical and
safety course member. He is based in                    ect on best guidance principles for the
                                                                                                           biosafety issues related to new scientific
Kenya and has written a laboratory safety               use of GM vectors. The meeting was co-
                                                                                                           endeavours. y
handbook.                                               ordinated by TDR’s Yeya Touré, formerly
                                                        of the Faculty of Medicine, Pharmacy and
“Not many Africans have been exposed
                                                        Dentistry, University of Bamako.                     Contact: Dr Yeya Touré
to biosafety,” said Tonui who is the found-                                                                tourey@who.int
er of an African Biological Safety Associa-             The third TDR-supported event, the

                                                                                                                                                           33
Sudan to develop a national HMM strategy
                                                                                                           Khaled Elmardi of the National Malaria
                                                                                                           Control programme. A second such proj-
                                                                                                           ect was then initiated in 2007-08 in North
                                                                                                           Kordofan state, funded by the Federal
                                                                                                           Ministry of Health. Positive results of these
                                                                                                           two projects inspired the Ministry to con-
                                                                                                           vene the workshop to develop a national
                                                                                                           HMM strategy across Sudan’s northern
                                                                                                           region in zones where malaria is endemic.

                                                                                                           The February workshop was facilitated by
                                                                                                           Hoda Atta, regional adviser for malaria in
Field visit to community medicine distributor in North Kordofan state, Sudan. Foreground, left to right:   EMRO, Marian Warsame of WHO’s Global
Mai M Alhilo, coordinator, Malaria Control Programme, North Kordofan, Sudan; Franco Pagnoni, TDR;          Malaria Programme and Franco Pagnoni
Tarig Abdelgadir, coordinator, National Malaria Control Programme, Federal Ministry of Health; Marian
Warsame (WHO/GMP); and Hoda Atta, regional advisor for malaria in WHO’s Eastern Mediterranean
                                                                                                           of TDR.
Regional Office. In background, left to right: Khalid A Elmardi, case management director, National
                                                                                                           The approximately 50 participants in-
Malaria Control Programme; Elrasheed M Ali, Partnership desk in National Malaria Control Programme.
                                                                                                           cluded representatives of high malaria-
                                                                                                           burden states as well as health officials
Sudan’s national malaria programme is                   ganized a two-day policy development
                                                                                                           from South and North Kordofan, where
developing a large-scale home manage-                   workshop in Khartoum, 3-4 February.
                                                                                                           the two pilot projects had taken place,
ment of malaria programme (HMM) for its
                                                        The workshop follows in the wake of a              and several high level officials from the
malaria-endemic zones in the country’s
                                                        TDR implementation research project                Federal Ministry of Health. The workshop
northern region as a result of implemen-
                                                        testing HMM strategies adapted to the              was preceded by a field visit to North
tation research stimulated by TDR.
                                                        country’s epidemiological and socio-               Kordofan, where participants were able
Sudan, the country in WHO’s Eastern                     cultural context.                                  to see first-hand how the home manage-
Mediterranean Region (EMRO) with the                                                                       ment of malaria project had been imple-
highest malaria burden, will thus be-                   The study was carried out in 2006 in the           mented. y
come the first country in the region to                 state of South Kordofan, in collabora-
develop and implement such an effort.                   tion with TDR/HQ, TDR/EMRO, Roll Back
                                                                                                             Contact: Dr Franco Pagnoni
In preparation for the new initiative, the              Malaria/EMRO and the Istituto Superiore            pagnonif@who.int
national malaria control programme or-                  di Sanità in Rome, Italy. It was led by
     No. 82




              Print and multimedia publications
              now available from TDR
                                                                               will	allow	clinical	laboratories	to	ensure	that	safety	and	
                 All TDR publications may be downloaded                        efficacy	data	is	repeatable,	reliable,	auditable	and	easily	
                 from the TDR website:                                         reconstructed	in	a	research	setting.	GCLP	guidelines	set	
                 www.who.int/tdr/publications                                  a	standard	for	compliance	by	laboratories	involved	in	the	
                                                                               analysis	of	samples	from	TDR-supported	clinical	trials.
                 To order hard copies free of charge, please fax
                 or mail us the attached publications order                    To download: http://www.who.int/tdr/svc/publications/
                 form, or e-mail your request to: tdr@who.int.                 tdr-research-publications/gclp-web


                                                                                Second edition: Good laboratory practice
                Evaluation of commercially available                            (GLP) handbook and training manuals
                anti-dengue virus immunoglobulin                                (Trainer and Trainee)
                M tests                                                         Web version only
                Diagnostics evaluation series, No. 3                           Handbook, 325 pp., 2009 (ISBN 978 92 4 154755 0)
               52 pp., 2008                                                    Trainer manual, 270 pp., 2009 (ISBN 978 92 4 154756 7)
                                                                               Trainee manual 271 pp., (ISBN 978
                                         Serological	assays	that	can	detect	
                                         virus-specific	immunoglobulin	        First	published	in	2001	to	assist	countries	in	conducting	

34                                       antibodies	to	dengue	virus	           non-clinical	research	and	drug	development,	the	GLP	
                                                                               series,	including	a	GLP Handbook	and	GLP Training
                                         are	widely	available	and	can	
                                         provide	an	alternative	to	more	       manuals	for	trainers	and	trainees,	has	been	revised	and	
                                         costly,	labour-intensive	methods	     updated	in	line	with	World	Health	Assembly	Resolution	
                                         of	diagnosing	dengue	fever.	          61.21,	Global strategy and plan of action on public health,
                                         However,	due	to	the	wide	variety	     innovation and intellectual property.	Since	the	publication	
                                         of	IgM	response	patterns	to	          of	the	first	GLP	series,	TDR-fostered	GLP	training	efforts	
                                         infection,	there	is	a	need	to	        have	resulted	in	a	network	of	GLP	trainers	whose	input	
               evaluate	the	sensitivity	and	specificity	of	available	tests.	   shaped	the	development	of	this	second	edition.	This	
               This	report	describes	the	results	of	a	TDR-sponsored	           revised	GLP	series	will	support	TDR	in	empowering	
               laboratory-based	evaluation	of	nine	commercially	               disease	endemic	countries	to	develop	and	lead	research	
               available	anti-DENV	IgM	tests.                                  activities	with	internationally	recognized	standards	of	
                                                                               quality.		
                                                                               To download: http://www.who.int/tdr/svc/publications/
                Good clinical laboratory practice (GCLP)                       tdr-research-publications/glp-handbook09-web
                Web version only
               28 pp., 2008 (ISBN 978 92 4 159785 2)

               In	2006,	WHO/TDR	convened	a	meeting	of	organizations	           available through TDR
               engaged	in	clinical	trials	in	disease-endemic	countries	
               to	discuss	the	applicability	of	GCLP	guidelines	to	their	       Evaluating diagnostics: the CD4 guide
               work.	It	was	agreed	that	GCLP	would	be	a	valuable	tool	         Nature Reviews Supplement: Microbiology
               for	improving	quality	laboratory	practice.	In	line	with	        Vol. 6, No.11, November 2008
               that	agreement,	TDR/WHO	recently	acquired	copyright	            Accurate	CD4	counts	are	crucial	laboratory	markers	for	
               to	GCLP	guidelines	that	were	originally	published	in	           assessing	immunodeficiency	and	the	risk	of	disease	
                                          2003	by	a	working	party	of	          progression	in	HIV-1	infection.	HIV-1	causes	a	huge	burden	
                                          the	Clinical	Committee	of	the	       of	morbidity	and	mortality,	particularly	in	developing	
                                          British	Association	of	Research	     countries.	This	fourth	supplement	in	the	series	focuses	on	
                                          Quality	Assurance	(BARQA),	          CD4	immunodiagnostics,	which	can	be	used	to	monitor	
                                          with	the	aim	of	disseminating	       CD4	counts	and	to	decide	when	to	treat	individuals	with	
                                          them	widely	in	developing	           antivirals	and	whether	treatments	are	effective.
                                          countries	and	developing	
                                                                               To download: http://www.nature.com/nrmicro/
                                          related	training	materials.	These	
                                                                               supplements/index.html
                                          GCLP	guidelines	are	presented	
                                          here.	Compliance	with	them	
                                                                                                                             No. 82



 Framework for operations and                               procedures	such	as	informed	consent	and	confidentiality.	
 implementation research in health and                      Those	presentations	formed	the	basis	for	this	book,	
 disease control programmes                                 subsequently	distributed	to	all	of	Brazil’s	550	institutional	
 Expert group report                                        ethics	review	committees	as	well	as	the	National	
37 pp., 2008 (ISBN 92 9224 110 9)                           Commission	on	Ethics	in	Research	(CONEP).	
                                                            For copies please contact: Dr	Iara	Coelho	Zito	Guerriero	at:	
The	product	of	a	joint	effort	by	the	Global	Fund	to	
                                                            guerriero@stu.ca
Fight	AIDS,	Tuberculosis	and	Malaria,	TDR	and	an	
inter-agency	technical	working	group,	this	IR/OR	
framework,	first	published	in	2008,	is	now	available	        A human rights-based approach
in	both	French	and	Spanish	along	with	the	initial	           to neglected tropical diseases
English	version.	The	overall	goal	of	the	framework	is	to	    WHO information sheet/web version
standardize	the	practice	of	OR	across	the	international	
                                                            Neglected	tropical	diseases	(NTDs)	affect	one	billion	
health	community	and	to	stimulate	the	integration	of	
                                                            people	around	the	world,	often	the	most	vulnerable	
OR	into	health	programmes.	Limited	number	of	hard	
                                                            populations	living	in	poor	rural	areas.	A	source	of	social	
copies	available	in	English,	French	and	Spanish.
                                                            stigma	and	poverty,	NTDs	can	result	in	lifelong	disability	
To download all three versions:                             and	even	death.	Affected	populations	often	do	not	
http://www.who.int/tdr/svc/publications/training-           have	access	to	treatment	and	preventive	measures,	and	
guideline-publications/listpubs                             research	and	development	have	been	insufficient.	This	
http://www.theglobalfund.org/en/me/?lang=en                 WHO	information	sheet,	developed	jointly	with	TDR	
                                                            andWHO’s	Department	of	Health,	Ethics	and	Trade,	aims	
                                                            to	improve	understanding	about	NTDs	among	health	
 Joint TDR/EC expert consultation on                        planners,	human	rights	groups,	development	partners	and	
 biomarkers in tuberculosis                                 civil	society	organizations.	Available	in	English,	French	and	
 Expert group report, TDR and the European
                                                            Spanish.                                                         35
 Commission
                                                            To download: http://www.who.int/tdr/svc/publications/
143 pp., 2008
                                                            tdr-research-publications/human-rights
The	emergence	of	multi-	and	extensively	drug	
resistant	tuberculosis	has	aggravated	the	impact	of	
                                                             New laboratory diagnostic tools for
TB,	especially	on	HIV-infected	individuals,	and	added	
                                                             tuberculosis control
urgency	to	the	search	for	new	vaccines,	diagnostics	
                                                             Stop TB Partnership: Retooling Task Force and New
and	drugs.	However	the	lack	of	suitable	and	validated	
                                                             Diagnostic Working Group
biomarkers	to	assess	areas	of	clinical	management	
                                                            January 2009
of	TB	patients	remains	a	major	obstacle	to	these	
efforts.	This	report	provides	an	overview	of	biomarkers	    There	is	a	lack	of	easily	digestible	information	available	to	
currently	under	study,	treatment	response	and	              national	tuberculosis	programmes,	as	well	as	to	funding	
outcomes,	technological	platform	s,	and	collaborations	     and	technical	agencies,	regarding	new	TB	diagnostic	tools	
between	researchers	and	funding	agencies.		                 in	the	development	and	implementation	pipeline.	

                                                            With	this	in	mind,	this	brochure	describes	19	new	or	
 Ethics in human and social sciences                        improved	diagnostic	tools,	among	the	many	such	
 research in the health field                               initiatives	under	way	worldwide.	Three	of	the	tools	
 Iara Coelho Zito Guerriero, Maria Luisa Sandoval           described	in	this	document	have	already	been	endorsed	
 Schmidt and Fabio Zicker                                   by	WHO	and	are	being	implemented	by	countries,	while	
 Sao Paulo: Editora Hucitec                                 the	others	are	still	under	development	or	in	piloting	phase,	
308 pp., 2008 (ISBN 978 85 60438 63 1)                      and	are	expected	to	be	ready	for	review	for	scaled-up	use	
                                                            in	the	coming	years.
Ethical	guidelines	issued	by	the	Council	for	
International	Organizations	of	Medical	Sciences	            The	brochure	represents	as	an	interim	document	until	
(CIOMS)	have	long	established	norms	for	the	conduct	        a	more	complete	blueprint	of	current	R&D	efforts	can	
of	biomedical	research.	However,	when	it	comes	to	the	      be	developed.	The	purpose	is	not	to	recommend	specific	
social	sciences,	the	guidance	has	never	been	so	clear.	     tools,	but	rather	to	provide	summary	information	about	
Thanks	to	a	TDR-supported	initiative	by	the	Health	         tools	being	developed	and	becoming	available,	so	that	
Secretary	of	Sao	Paulo,	Brazil,	this	may	soon	change	       all	who	play	a	part	in	TB	control,	especially	in	national	TB	
in	Brazil.	A	2007	seminar	in	Sao	Paulo	addressed	the	       programmes,	can	make	well-informed	decisions	when	
ethical	challenges	unique	to	qualitative	social	sciences	   retooling.
research,	particularly	in	developing	countries.	More	       To download: http://www.who.int/tdr/svc/publications/
than	150	participants	presented	on	issues	ranging	          non-tdr-publications/diagnostic-tool-tb
from	the	ethics	of	ethnographic	studies	involving	
vulnerable	populations	to	issues	related	to	specific	
          No. 82




     Call for contributions                                 The	call	includes	requests	for	contributions	of:	

                                                            •	 Studies, publications or reports	that	
     Call	for	contributions	to	a	WHO	systematic	
                                                               monitored	pregnant	women	in	Africa,	Asia	
     review	of	information	on	maternal	outcomes	
                                                               or	Latin	America,	and	assessed	the	newborn	
     and	prevalence	of	birth	defects	in	Asia,	Africa	
                                                               at	birth.
     and	Latin-America.
                                                            •	 Individual patient data	from	research	in	
     WHO/TDR	are	issuing	two	calls	for	
                                                               Africa,	Asia	or	Latin	America,	where	pregnant	
     contributions	to	this	planned	systematic	
                                                               women	were	prospectively	followed	to	term,	
     review,	which	is	part	of	a	broader	WHO	effort	
                                                               and	where	the	newborn	has	undergone	a	
     to	establish	a	Global	Pregnancy	Register	(see	                                                                                   is published three
                                                               systematic	physical	examination.
     page	6).	                                                                                                         times a year by the Special Pro-
                                                                                                                       gramme for Research and Training
                                                                                                                       in Tropical Diseases (TDR), spon-
                                                                                                                       sored by UNICEF/UNDP/World Bank
     Please	contact	Dr Melba Gomes	(gomesm@who.int)	with	either	“Systematic	review	of	pregnancy	                       and WHO.
     outcomes	-reports”	or	“Systematic	review	of	pregnancy	outcomes	–	Individual	Patient	Data”	in	the	
     subject	line	of	the	message	if	you	have	information	to	contribute.	                                               Both html and PDF versions of the
                                                                                                                       newsletter are available on the TDR
     Reprints	of	relevant	publications/reports	can	be	mailed	to:                                                       website. All material submitted
                                                                                                                       to TDRNews undergoes editorial
     Dr	Melba	Gomes,	scientist,	                                                                                       review. Articles and illustrations
     Special	Programme	for	Research	and	Training	in	Tropical	Diseases	(TDR)	                                           published in TDRNews which are
     World	Health	Organization,	                                                                                       not copyrighted may be reproduced,
     20	Avenue	Appia, 1211	Geneva,	Switzerland                                                                         provided credit is given to TDR and
                                                                                                                       provided such reproduction is not
                                                                                                                       used for commercial purposes.
                                                                                                                       Articles do not necessarily reflect



                              Grant awards
                                                                                                                       the views of WHO.
36
                                                                                                                       To our readers:
                                                                                                                       We want to hear from you.
Innovative vector             A80309                        A80344                       including genetic diversity   Please send us your feedback,
control interventions         Brij Kishore TYAGI            Hiba Mohamed ABDALLA         of dengue virus serotypes     as well as letters and ideas on
(BL5)                         Centre for Research in        Blue Nile National           from dengue cases.            possible stories for TDRNews
                              Medical Entomology,           Institute for                A80331                        and on TDR-related tropical
TDR’s Strategic and           ICMR, Madurai, INDIA.         Communicable Diseases,                                     disease research issues, events,
                                                                                         Amare Deribew TADEGGE
Scientific Advisory           Asian centre for training     Wad Medani, SUDAN.                                         institutions, publications and
                                                                                         Jimma University,
Committee on                  in biosafety assessment                                                                  personalities. Thank you!
                                                            Insecticide resistance in    Jimma, ETHIOPIA.
Innovative Vector             for human health and          malaria vectors in central   Evaluation of operational
Control Interventions         environment using             Sudan.                       performance of the revised
recommended the               genetically modified
following projects                                          A80345                       recommendations &
                              vectors.
for funding in 2008                                         Mariam ALLY                  algorithms of WHO for
                              US$ 50 000
in response to calls                                        Ministry of Health and       improving diagnosis of TB.
for proposals from            A80310                        Social Welfare, Dar es       A80328
investigators worldwide.      Ivan Dario                    Salaam, TANZANIA.            Tashi TOBGAY
                              VELEZ-BERNAL                  Equity in health financing   Vector Borne Disease
A80361
                              Universidad de Antioquia,     and beneift incidence        Control Programme,
Seydou DOUMBIA
                              PECET, Medellin,              in Tanzania: Could           Ministry of Public Health,
University of Bamako,
Faculty of Medicine,          COLOMBIA.                     prepayment schemes be a      Thimphu, BHUTAN.
Pharmacy and dentistry,       Latin American biosafety      solution?                    Reaching malaria
                              training centre in relation                                                              address
MALI.                                                                                    treatment in the remote
                              to potential release of
                                                            A80382                                                     TDR
Evidence-basis for the                                                                   malarious areas of Bhutan.
                              genetically modified          Ivan EMIL                                                  World Health Organization
improvement of integrated
                                                            Kigali Health Institute,     A80338                        20, Avenue Appia
malaria vector control        disease vectors.
                                                            Kigali, RWANDA.              Fadima YAYA BOCOUM            1211 Geneva 27
strategies in East, Central   US$ 50 000
                                                            Impact of de-worming &       Institut de Recherche         Switzerland
and West Africa.
                                                            prevalence of helminths      en Sciences de la Santé,
US$ 200 000                   Empowerment                                                                              Fax: (+41) 22 791-4854
                                                            & HIV co-infections          Ouagadougou,                  tdr@who.int
A80360                        Function (BL2)
                                                            in pregnant women            BURKINA FASO.                 www.who.int/tdr
Maria Inés PICOLLO                                          attending antenatal          Scaling up the antenatal
                              TDR’s Strategic and
Centro de Investigaciones
                              Scientific Advisory           services.                    syphilis screening in
de Plagas e Insecticidas,     Committee for                 A80350                       Burkina Faso.
Villa Martelli, ARGENTINA.    Empowerment
Design and evaluation                                       Shyam Prakash DUMRE
                              recommended the
of complementary or           following Leadership          National Public Health
                                                                                                                                    Special Programme for Research & Training
alternative strategies for    Training Grants to            Laboratory, Kathmandu                                                   in Tropical Diseases (TDR) sponsored by
                                                                                                                                    U N I C E F / U N D P / W o r l d B a n k / W H O
the control of Chagas         researchers in 2008, in       Teku, NEPAL.
disease vectors.              response to a global call     To determine the
US$ 193 000                   for LTG proposals.            molecular epidemiology
                                                                                                                                                   ISSN 1028-5911
                                                                                                                             DOI: 10.2471/TDR.09.TNL.82.1028-5911
                                                                                                                       Special Programme for Research & Training
                                                                                                                       in Tropical Diseases (TDR) sponsored by

				
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