Samples Letters of Clinical Recommendations by xso77287

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									    Food and Drug Series                                                                              March	2008	|	Vol.	15,	No.	6


Federal Panel Recommends                                                      Also In This Issue
Extending HIPAA Requirements                                                  HIPAA	Panel	Recommendations	Focus	on	
   The	National	Committee	on	Vital	and	Health	Statistics,	a	federal	          Research	............................................................5
advisory	panel	to	the	Department	of	Health	and	Human	Services	                Hold	on	Device	Trial	Registration	information	
(HHS),	has	called	for	“enhanced	protections	for	all	uses	of	health	                                                   .
                                                                              Could	Cause	Later	Publication	Problems	.......10
data	by	all	users,”	independent	of	whether	the	organization	involved	         CED	Coverage	of	Artificial	Heart	Trials	
is	covered	by	the	Health	Insurance	Portability	and	Accountability	            Proposed	..........................................................11
Act	(HIPAA).	The	panel	also	recommended	that	an	individual’s	
authorization	be	obtained	for	the	collection,	use,	and	disclosure	of	         OHRP	Expands	International	Rules	List	.........17
personal	health	information	by	organizations	not	covered	by	HIPAA.	           Studies on Studies
The	panel	also	said	HHS	should	work	with	other	federal	agencies	              Study	Finds	Duplicative	Articles	a	‘Persistent	
and	Congress	to	develop	“more	inclusive	federal	privacy	legislation	          Problem’	..........................................................12
so	that	all	individuals	and	organizations	that	use	and	disclose	indi-
                                                                                                                  .
                                                                              Study	Shows	Blacks	Distrust	Research	..........14
vidually	identifiable	health	information	are	covered.”	Page 2
                                                                              Another	Study	Finds	Age,	Race	Disparities	in	
Supreme Court Declines To Hear                                                Cancer	Studies	.................................................14

Abigail Alliance Appeal                                                       Checklist	for	Informed	Consent	Does	Not	
                                                                              Improve	Subject	Understanding	......................15
   The	U.S.	Supreme	Court	declined	without	comment	to	hear	
                                                                              More	Clinical	Trials	Available	to	Younger	
an	appeal	of	a	U.S.	appeals	court	en	banc	ruling	that	rejected	that	          Cancer	Patients	................................................15
terminally	ill	patients	have	a	“fundamental	right”	to	access	to	in-
vestigational	new	drugs	(Abigail Alliance for Better Access to Devel-         State Roundup
opmental Drugs v. von Eschenbach,	U.S.,	No.	07-444,	review	denied	            N.J.	Legislature	Considers	Trial	Registration	.16
1/14/08).	The	full	U.S.	Court	of	Appeals	for	the	District	of	Columbia	        New	Jersey	Governor	Signs	Law	Allowing	
Circuit	ruling	in	August	2007	affirmed	an	August	2004	opinion	from	           Surrogate	Informed	Consent	...........................18
the	U.S.	District	Court	for	the	District	of	Columbia	and	overturned	
                                                                              Ohio	Senate	Passes	Bill	Mandating	Insurance	
a	May	2006	court	of	appeals	panel	ruling	that	in	cases	where	there	
                                                                              Coverage	for	Clinical	Trials	............................18
are	no	other	FDA-approved	treatment	options,	a	terminally	ill	patient	
has	a	“fundamental	right”	protected	under	the	U.S.	Constitution’s	due	        Oklahoma	Bill	Provides	for	Insurance	Coverage	
process	clause	to	have	access	to	investigational	new	drugs.	Page 7            Of	Cancer	Clinical	Trials.................................18

                                                                              Miss.	Bill	Calls	for	Result	Disclosure	.............19
ClinicalTrials.gov Hits 50,000                                                D.C.	Council	Considers	Insurance	Coverage	for	
Registrations with FDAAA                                                      Routine	Trial	Costs	..........................................19

   More	than	50,000	clinical	trials	are	listed	on	ClinicalTrials.gov	                                               .
                                                                              Hawaii	Considers	Tax	Credit	for	Trials	 ..........20
with	nearly	2,000	trials	posted	between	the	end	of	2007	and	early	            FDA Warning Letters .........................2
2008,	as	sponsors	rushed	to	meet	the	registration	requirements	
                                                                              OHRP Determination Letters ............22
of	the	FDA	Amendments	Act	of	2007	(FDAAA).	As	of	Dec.	27,	
                                                                              News Briefs ........................................23
2007,	there	were	48,656	trials	registered	on	ClinicalTrials.gov.	That	
number	grew	to	50,629	on	Feb.	5.	Nicholas	Ide,	chief	architect	of	
ClinicalTrials.gov,	said	there	was	an	increase	in	the	number	of	reg-          Contact Us
istrations	to	meet	the	FDAAA	deadline	but	not	the	“tidal	wave”	that	          Customer Service: 800	677-3789
hit	the	site	when	companies	scrambled	to	meet	medical	journal	reg-            Online: www.thompson.com
istration	requirements	in	2005.	Page 8                                        Editorial: 202	872-4000


	                                      March	2008	|	Guide to Good Clinical Practice                                                                    

								
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