clinical research in malaysia nih 20081025 2

8/8/2019 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







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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







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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







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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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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



Clinical trial registrationFunding for 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



Clinical trial registrationFunding for 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

clinical research in malaysia nih 20081025 2

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