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A Ministry of Health Perspective

 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research
 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research
 


  

a 







, including
research development, testing and
evaluation, designed to develop or contribute
to  
  
 m

  


A quality improvement process that seeks to
improve patient care and outcomes through
systematic review of care against explicit criteria
and the implementation of change. Aspects of the
structure, processes and outcomes of care are
selected and systematically evaluated against
specific criteria. Where indicated, changes are
implemented at an individual, team or service level
and further monitoring is used to confirm
improvement in healthcare delivery

NICE (2002) ³Principles for Best Practice in Clinical Audit´

  


  

Research asks ³What¶s the right thing to do?´

Audit asks ³It is done right?´
˜




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Clinical research is defined as patient-

oriented research conducted with human
subjects (or on material of human origin
such as tissues, specimens and cognitive
phenomena) for which an investigator (or
colleague) directly interacts with human
subjects.
Excluded from this definition are in vitro
studies that utilise human tissues that cannot
be linked to a living individual.
˜




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Patient-oriented research includes:

a)Mechanisms of human disease,
b)Therapeutic interventions,
c) Clinical trials,
d)Development of new technologies,
e)Epidemiologic and behavioral studies, and
f) Outcomes research and health services
research.
 4




 

›
 
means a living individual
about whom an investigator conducting
research obtains
Data through intervention or interaction with the
individual, or
Identifiable private information
 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research






 

   

Establish organisational framework for

support of research
Establish infrastructure to facilitate and
support research
Develop guidelines to facilitate approval and
conduct of research
Increase funding for research
Develop biotechnology
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encourage health research to support health
services and health management
encourage networking and linkages between
the institutes of the NIH & other research
agencies
produce new discoveries to strengthen and
develop health systems and up-to-date
technologies
˜

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A steering committee for clinical research

was established in 1997
To coordinate and promote clinical research
Enhancing clinical research through
collaboration between MOH, academia and
pharmaceutical industries
To establish policy and plan clinical research
To improve infrastructure
 
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Health research disease priorities (July
2006)
IHD
Mental Disease
CVD
Stroke
Cancers
Diabetes
Respiratory Diseases
Road Traffic Accidents
Selected Infectious Disease of Major Public
Health Problems
 ˜

 


 


Healthcare biotechnology
One of the nine main thrusts to realize
Malaysia¶s potential in the biotechnology sector
Capitalise on the country¶s biodiversity for
commercialising the discoveries of health related
natural products and bio-generic drugs.
  


 

Dedicated one-stop agency to manage the

development of the biotechnology industry
Priority focus areas for healthcare industry:
Contract Manufacturing
Contract Research
Clinical Trials
Diagnostic & Biomedical Instruments
Vaccines
Natural Substance
Nutraceutical
m!


 


 

Secure cooperation from all stakeholders

towards facilitating and expediting the creation
of a conducive environment
Encourage more private sector involvement and
investment in the biotechnology industry
Lead the implementation of agreed
biotechnology initiatives
   4

government agency responsible for the promotion

& coordination of industrial development
1st point of contact for investors who intend to set
up projects in the manufacturing and services
sectors in Malaysia
Provide incentives
Pioneer status/income tax exemption
Investment tax allowance
Bionexus status IT exemption
 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research
˜  
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Ref: DiMasi a JA, W. Hansen RW, Grabowski HG. The price of

innovation: new estimates of drug development costs Journal of Health
Economics 22 (2003) 151±185
 
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Contract Clinical Research Industry has emerged
over the last 20 years to serve the Pharma/Biotech
industries by providing more efficient and cost
effective clinical development services
And increasingly Pharma/Biotech industries or their
CROs are also offshoring clinical trials to emerging
markets, including Asia
°



 

 
 
 
 



 

 





 
 Tufts Outlook
2007 Report, 3 January 2007
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Region Average relative annual growth rate

East Europe 24%

Asia 20.4%

Latin America 19.8%

West Europe 3.5%

North America -6.9%

Ref: 



 
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Ranking Country Sites Shares ARAGR Global
Ranking
1 China 533 0.7 47.0 1
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 &(& )$' *'$& +
3 Philippines 178 0.2 30.9 8
4 H. Kong 111 0,1 26.5 13
5 Thailand 133 0.2 26.4 14
6 India 757 1.0 19.6 20
7 S. Korea 466 0.6 17.9 23
27 Taiwan 420 0.6 13.9 27
9 Japan 2002 2.7 10.3 31
10 Australia 1131 1.5 8.1 34
11 Singapore 86 0.1 7.1 36
12 N. Zealand 138 0.2 5.9 37
Trials beginning 2002-2006
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Network of CRC launched in April 2007

One-stop centre to promote Malaysia as a
preferred clinical trial site
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The One Stop Centre CRC provides a single

point of contact and facilitate industry¶s access
to investigators and patients for purpose of
contract research
To provide infrastructure and practical plan to
support professional and efficient clinical trials
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Industry Sponsored 23 55

Investigator 72 105
Initiated
Not Available 0 4


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first line of contact for industry, identify and recruit

suitable investigators
feasibility assessment for trial proposal submitted
by industry
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assist with ethics & regulatory submissions

pre-screening of patients at non-participating
sites for enrollment into trial
establish and update Investigator Database
 




  
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Total No of Feasibilities : 126

 



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Cardiology : 8 Oncology : 18
Medicine : 6 Psychiatry : 12
Oncology : 5 DM : 8
Nephrology : 4 Nephrology : 7
 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research
  

  




Transparency in conducting and reporting clinical
trials
Avoid selective reporting
There is a need to ensure that decisions about health
care are informed by all of the available evidence
It is difficult to make informed decisions if publication
bias and selective reporting are present
Sharing of knowledge
Avoid unnecessary duplication of trials
Improving awareness of similar or identical trials will
make it possible for researchers and funding agencies to
avoid unnecessary duplication
Parameter Published Number 95% CI
needed
Response Yes NNB 10 5-@

SAE Yes NNH @ 34 - @

Suicidal ideation Yes NNH 50 25 - @ to NNB 100

& attempts
Parameter Published Number 95% CI
needed
Response Yes NNB 10 5-@

Remission No NNB 34 5 - @ to NNH 8

SAE Yes NNH @ 34 - @

Suicidal ideation Yes NNH 50 25 - @ to NNB 100

& attempts
  

  




To identify gaps in clinical trials research
Enhance public confidence
Facilitate recruitment
researchers and potential participants aware of recruiting
trials
Enhance collaboration among researchers
including meta-analysis

 



 
 
 
 

 
 
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PLoS Med. 2005 Nov;2(11):e378.

 m1
 



ClinicalTrials.gov www.clinicaltrials.gov

Australian New Zealand Clinical Trials www.anzctr.org.au

Registry (ANZCTR)
ISRCTN.org www.isrctn.org

UMIN Clinical Trials Registry (UMIN- www.umin.ac.jp

CTR)
The Netherlands National Trial www.trialregister.nl
Register (NTR)
˜

 
  



https://www.nmrr.gov.my
 ˜





All research require prior registration with and

approval by the MOH.
All research undertaken by MOH personnel OR
conducted in MOH facilities OR funded by MOH
research grant shall require:
prior registration with the NMRR
prior approval by the MOH
˜ 








  

 


 


 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research
  
  

Governmental
Ministry of Health (MOH)
NIH funding under 9th MP
Major Research Grant
Minor Research Grant
Ministry of Science, Technology and Innovation
(MOSTI)
Science Fund
TechnoFund
 p  

Science Fund
supports basic and applied science research
biotechnology is supported
TechnoFund
commercialization of research
  
 m

  

International Agencies
WHO/WPRO/SEAMO-TROPMED etc.
Professional Organizations/NGOs
MAKNA, etc
Private industry
multinational pharmaceutical companies
Universities
 p


What is Clinical Research?
Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registration
Funding for research
Challenges in clinical research
 m
 

Human resource
Researchers, Supportive staff
Oversight & governance
Ethical conduct of research
Resources (funding)
Infrastructure
Publications
Commercialisation
 m 


Clinical research activities have improved

Clinical research will develop further in the
future with recent initiatives taken by the
MOH
Human resource development is critical to
future success
Challenges to overcome