NZ_Clinical_Research_27August by mudoc123


									               Science R & D Innovation
Knowledge Ware Trust 2002 „The Missing Billion‟

Speech from the Throne 2005 „Science critical to driving New Zealand Economy‟

Prime Minister John Key 2009 „Science and innovation will be at the centre of my government‟

                                       NZ                  OECD Average

Public Investment R & D                0.54 % GDP          0.68% GDP

Private Investment R & D               0.44% GDP           1.5% GDP
      Improving NZ Environment To Support
        Innovation Through Clinical Trials

•“Prof. Shaun Holt „our ethics system is now so unwiedly, its
unethical” – NZ Herald March 2009
•Prof. Tim Dare “Health Ethics Committee up with world
standards” – NZ Herald 16 March 2009
•Holt “Problems with Ethics Committee – lack of expertise,
overly bureaucratic, complicated application forms, slow…”
•Rudd Government Taskforce 2009 “To make Australia the
best place in the world to carry out clinical trials. Report due
April 2010?
     Improving NZ’s Environment to Support
       Innovation Through Clinical Trials
New Zealand: Phase I-IV trials worth $12 - $20 million
Australia: Phase I-IV trials worth $450 million
Terms of Reference
•Co-ordinated, nationwide approaches to clinical trials
•Streamline ethics approval systems
•National patient referral networks
•Removal unnecessary barriers
•How to benefit the NZ innovation system, health system, & economy
Rationale – Multibillion Dollar Industry
•Good for patients, standards, health systems, scientists
•Good to stimulate biopharmaceutical, functional food and medical
device industry in New Zealand – good for the economy.
                    ? The Missed Opportunity
Glaxo Smith Kline          2007 Turnover   $66 billion dollars per year
                           R&D spend       $10 billion New Zealand dollars

                                                                             London 1921

Bunnythorpe 1900

  Glaxo Foot Rot Vacinne
       Singapore – The Biopolis of Asia

“You can‟t buy Wrigley‟s Spearmint gum in Singapore. But human
embryonic stem cells? That‟s a different matter…”
Auckland’s Ruby World Cup Party Zone – Artist’s Impression
       Professor Shaun Holt, Geoffrey Horne

•Should have smaller committees – 7 rather than 12
•No need to have Justice of the Peace sign off
•No need to consult Maori every study
•No need for locality assessment forms
•Simple 1-2 page applications system for simple studies
•On line applications – forms reduced by 50%
•Committee lead reviewer for each study should email
researcher to clarify any potential ethical problems before the
•Letters should be emails to researcher within 3 days of
     Recommendations for Improvement –
  Chairs/Health and Disability Ethics Committee
•Introduce an on-line application and approval process. Improve
application form to remove repetition and ambiguity.
•Provide a central clearing house to allow researchers to have their
application reviewed by their regional committee, or by the committee
meeting next if they want their application fast tracked.
•Ensure that there is at least one Ethics Committee meeting
somewhere in the country every week, except for the Christmas/New
Year period.
•Retain regional committees to facilitate attendance by researchers.
Where this is happening applications are approved more quickly and
good working relationships have developed.
•Establish a dedicated committee for sponsored clinical trials for which
a fee will be charged.
      Recommendation for Improvement cont’d
•Consider reducing membership to 10 but retain 50% balance lay/non-lay
membership. Public confidence and quality are essential and a
comprehensive mix of skills supports thorough analysis and sound
outcomes. A pool of experts could be established whose advice could be
drawn upon as needed.
•Terms of reference for expedited review be considered with a view to
widening scope where appropriate.
•Establish review turnover times as a monitored performance measure.
•Enable researchers to instigate minor amendments and inform
•Update the Operational Standard to cover areas where there is
inconsistency and provide appropriate and timely training for all committee
  Medical Technology Association of NZ (MTANZ)
Medical technology industry
•Annual turnover $1.3 billion             2008/2009
•Export income $333 million               200707/2008
•Employs ≥ 6000 people
•Research investment $56.6 million        2007/2008
•A better understanding of the differences between medical technologies &
pharmaceutical and the data required to support the respective products
through development.
•A centralised ethics process in order to speed up the approval process.
•Ethics committee to engage with applicant in meaningful dialogue that is
transparent with feedback.
•Ethics committee to have a formalised monitoring programme with agreed
time lines for applicants.
       Medical Technology Association of NZ
                  (MTANZ) cont’d
•A mutually agreeable standardise Indemnity Agreement (IA)
& Clinical Trial Agreement (CTA) should be developed.
•Better access to clinicians & better support from the public
hospitals for local medical technology industry.
•Government support (financial support through grants, in-kind
support, tax concessions…) for all phases of clinical research
– from new technology innovation, to proof of concept trials, to
multicentre global studies.
•Mutual Recognition Arrangement (MRA) between Australia &
New Zealand for the ethics process.
                  NZ BIO Submission

•NZ develop a notification system similar to Australia –
recommends Clinical Trial Notification (CTN)/exemption (CTX)
•That operating guidelines to Medsafe, SCOTT & GTAC,
expressly encourage meeting with sponsors before an
application is submitted & after it has been reviewed.
•That overseas experts should be considered to expand the
talent pool for SCOTT.
•That the process for trials involving functional foods be
separated from the therapeutic clinical trial process &
simplified to remove non-relevant requirements such as
toxicology studies on food with a long history of safe
                             Realising NZ’s Potential
                     minimise systemic weaknesses (Roche)
Speed to start up
•Improvements in Ethical review
     –Ethics approval in parallel timeframe to SCOTT
     –Invest in electronic information management (online submissions)
     –Networked decision making (committee need not “sit”)
Increased capacity & capability
•Regionalisation of Research Development Offices
     –Decreased duplication amongst DHBs, ethics committees & SCOTT
     –Nationally consistent infrastructure & culture to support clinical trials
           •Establish & collect performance metrics
           •Public education & participation
•Cohesive policy development, process improvements
     –Privacy Act
•Uniform focus on professional development & training
     –Accredited training & career pathways
•Optimal resource management & cost containment
Electronic patient database & patient referral networks
•Patient identification & recruitment
•NHB IT Board
     Innovation in NZ Health Delivery Research
     Weakly distribute policy & investment (Roche)
“Igniting Potential” NZ’s Science and Innovation pathway strategy
•Health & Society research sector outcomes 1/6th of focus
•No specific policy directions from this sector
MOH does not have a research strategy
Research specifically excluded from DHB operational funds
•DHB Staff involvement in research not regarded as legitimate activity
    –Core job responsibility
NZ Government funding per capita for health research 1/3 Australia,
1/5 UK, 1/10 USA.
Responsibility for policy & funding of health delivery research
distributed across multiple agencies (e.g. FRST, MORST, HRC, MoH)
•Contrast UK NIHR, Australia NHMRC
       Number of Industry Funded Studies
               Listed in (Roche)

220                                                          Russia
200                                                          Korea
180                                                          India
160                                                          Brazil
140                                                          Mexico
120                                                          China
100                                                          Turkey
 80                                                          NZ
      2005   2006        2007          2008           2009
                                South Korea
   Government Investment Critical Success Factor (Roche)

Regional Clinical Trial Centres (CTC) programme
supported by the MOHW (Ministry Health & Welfare)
•14 centres of excellence established
•USD – 4 million per centre & matching fund from each
“One of the key factors in boosting the growth of clinical trials in Korea was
the government recognition of their key role in driving the development of
the biotech & pharmaceutical industries, as a truly knowledge-based

Ref: Prof San_Goo Shin. President of KoNECT December 2008 interview, KoNECT website
News Board
      Improving NZ’s Environment to Support
         Innovation through Clinical Trials

•Robustness of ethical evaluation must remain
•Room for significant efficiencies in process
Task for Health Select Committee
•Analyse the 71 submissions, advisors from Ministry of Health
and MORST along with independent advisor David Clarke,
•Make recommendations, to make NZ environment, best
practice, (best in the world) to carry out clinical trials.

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