Clinical Research in Malaysia NIH 20081025 2
Transcript of Clinical Research in Malaysia NIH 20081025 2
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Clinical Research in Malaysia
A Ministry of Health Perspective
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Outline
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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Outline
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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What is research?
a systematic investigation, includingresearch development, testing and
evaluation, designed to develop or contribute
to generalisable knowledge
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Clinical audit
A quality improvement process that seeks toimprove patient care and outcomes throughsystematic review of care against explicit criteriaand the implementation of change. Aspects of the
structure, processes and outcomes of care areselected and systematically evaluated againstspecific criteria.Where indicated, changes areimplemented at an individual, team or service leveland further monitoring is used to confirm
improvement in healthcare delivery
NICE (2002) Principles for Best Practice in Clinical Audit
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Research vs clinical audit
Research asks Whats the right thing to do?Audit asks It is done right?
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NIH definition of Clinical Research
Clinical research is defined as patient-oriented research conducted with human
subjects (or on material of human origin
such as tissues, specimens and cognitivephenomena) 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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NIH definition of Clinical Research
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.
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Definition of human subject
Human subjectmeans a living individualabout whom an investigator conducting
research obtains
Data through intervention orinteraction with theindividual, or
Identifiable private information
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Outline
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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Initiatives to develop clinical research
Establish organisational framework forsupport of research
Establish infrastructure to facilitate and
support researchDevelop guidelines to facilitate approval and
conduct of research
Increase funding for researchDevelop biotechnology
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Institute for Medical Research
(IMR)
Institute of Public
Health (IPH)
Institute ofHealth
Management (IHM)
Clinical Research
Centre (CRC)
Institute forHealth System
Research (IHSR)
Institute ofHealth
Promotion (IHP)
National Institute ForNatural
Products and Vaccinology (9Bio)
NATIONALINSTITUTES OF HEALTH
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Objective ofNIH
encourage health research to support healthservices and health management
encourage networking and linkages betweenthe institutes of the NIH & other researchagencies
produce new discoveries to strengthen anddevelop health systems and up-to-date
technologies
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National Committee for Clinical Research
A steering committee for clinical researchwas established in 1997
To coordinate and promote clinical research
Enhancing clinical research throughcollaboration between MOH, academia and
pharmaceutical industries
To establish policy and plan clinical researchTo improve infrastructure
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Malaysian GCP guideline
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9th MP: Health research priorities
Health research disease priorities (July2006)
IHD
Mental Disease
CVD
Stroke
Cancers
DiabetesRespiratory Diseases
Road Traffic Accidents
Selected Infectious Disease of Major Public
Health Problems
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National Biotechnology Policy
Healthcare biotechnologyOne of the nine main thrusts to realize
Malaysias potential in the biotechnology sector
Capitalise on the countrys biodiversity for
commercialising the discoveries of health related
natural products and bio-generic drugs.
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Role of Biotechcorp
Dedicated one-stop agency to manage thedevelopment of the biotechnology industry
Priority focus areas for healthcare industry:
Contract ManufacturingContract Research
Clinical Trials
Diagnostic & Biomedical Instruments
Vaccines
Natural Substance
Nutraceutical
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CWG on Healthcare Biotechnology
Secure cooperation from all stakeholderstowards 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
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Role of MIDA
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 allowanceBionexus status IT exemption
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Outline
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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New drug development & Clinical trials..
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And it is hugely costly.
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) 151185
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Clinical trial market growth rate
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: Fabio A. Thiers, Anthony J. Sinskey and Ernst R. Berndt.
MIT Center for Biomedical Innovation, Nov 2007
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Asian Top 12 Fastest Growing Clinical Trial Market
Ranking Country Sites Shares ARAGR Global
Ranking
1 China 533 0.7 47.0 1
2 Malaysia 161 0.2 32.1 5
3 Philippines 178 0.2 30.9 8
4 H. Kong 111 0,1 26.5 135 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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No. of clinical trials conducted in Malaysia
4
7
7 8 4 7
Source: National Pharmaceutical Control Bureau. No. of applications for theclinical trial import license for unregistered products.
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Malaysia as a clinical trial hub
Network of CRC launched in April 2007One-stop centre to promote Malaysia as a
preferred clinical trial site
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Network of CRCs, MOH
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SMO function ofthe OSC
The One Stop Centre CRC provides a singlepoint of contact and facilitate industrys access
to investigators and patients for purpose of
contract research
To provide infrastructure and practical plan tosupport professional and efficient clinical trials
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Clinical Trials
Clinical Trials Captured on NMRR
(259)
Sponsorship 200 200
Industry Sponsored 23 55
Investigator
Initiated
72 105
Not Available 0 4
Total 95 16
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One stop-centre
first line of contact for industry, identify and recruitsuitable investigators
feasibility assessment for trial proposal submitted
by industry
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One stop-centre
assist with ethics & regulatory submissionspre-screening of patients at non-participating
sites for enrollment into trial
establish and update Investigator Database
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Feasibility Study Performance
2007 2008
(till September)
Total Number of Feasibility Studies 43 83
Total Number of Investigators Approached 733 1545
Total Number of Clients Served 15 23
Average Number of Investigators
Approached / Assignment
17 19
Average Number of Responses / Assignment 12 13
Average Number of Positive Responses /
Assignment
5 5
Total No of Feasibilities : 126
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Feasibility : Therapeutic Areas
HighestNo of Feasibility Assignments According to
Therapeutic Area
200 200
Cardiology : 8
Medicine : 6
Oncology : 5
Nephrology : 4
Oncology : 18
Psychiatry : 12
DM : 8
Nephrology : 7
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Outline
What is Clinical Research?Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registrationFunding for research
Challenges in clinical research
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Reasons fortrial registration
Transparency in conducting and reporting clinicaltrials
Avoid selective reportingThere is a need to ensure that decisions about healthcare are informed by all of the available evidence
It is difficult to make informed decisions if publicationbias and selective reporting are present
Sharing of knowledge
Avoid unnecessary duplication of trialsImproving awareness of similar or identical trials willmake it possible for researchers and funding agencies toavoid unnecessary duplication
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Parameter Published Number
needed
95% CI
Response Yes NNB 10 5 - g
SAE Yes NNH g 34 - g
Suicidal ideation
& attempts
Yes NNH 50 25 - g to NNB 100
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Parameter Published Number
needed
95% CI
Response Yes NNB 10 5 - g
Remission No NNB 34 5 - g to NNH 8
SAE Yes NNH g 34 - g
Suicidal ideation
& attempts
Yes NNH 50 25 - g to NNB 100
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Reasons fortrial registration
To identify gaps in clinical trials researchEnhance public confidence
Facilitate recruitment
researchers and potential participants aware of recruiting
trials
Enhance collaboration among researchers
including meta-analysis
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Trial Registration Protocol Items proposed by pharmaceutical industry, the WHO
and the Ottawa Group
PLoS Med. 2005 Nov;2(11):e378.
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ICMJE accepted registries
ClinicalTrials.gov www.clinicaltrials.gov
Australian New Zealand Clinical Trials
Registry (ANZCTR)
www.anzctr.org.au
ISRCTN.org www.isrctn.org
UMIN Clinical Trials Registry (UMIN-
CTR)www.umin.ac.jp
The Netherlands National Trial
Register (NTR)
www.trialregister.nl
National Medical Research Register
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National Medical Research Register
https://www.nmrr.gov.my
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NIH Policy Statement
All research require prior registration with andapproval 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
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New User Registration
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Registration of new research
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Research database
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Research database
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Outline
What is Clinical Research?Initiatives to develop clinical research
Malaysia as a clinical trial hub
Clinical trial registrationFunding for research
Challenges in clinical research
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Funding for Research
GovernmentalMinistry of Health (MOH)
NIH funding under 9th MP
Major Research Grant
Minor Research GrantMinistry of Science, Technology and Innovation
(MOSTI)
Science Fund
TechnoFund
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MOSTI grant
Science Fundsupports basic and applied science research
biotechnology is supported
TechnoFundcommercialization of research
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Funding for Clinical Research
International AgenciesWHO/WPRO/SEAMO-TROPMED etc.
Professional Organizations/NGOs
MAKNA, etcPrivate industry
multinational pharmaceutical companies
Universities
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Challenges
Human resourceResearchers, Supportive staff
Oversight & governance
Ethical conduct of researchResources (funding)
Infrastructure
PublicationsCommercialisation
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Conclusions
Clinical research activities have improvedClinical research will develop further in the
future with recent initiatives taken by the
MOHHuman resource development is critical to
future success
Challenges to overcome