Clinical Research in Malaysia

A Ministry of Health Perspective

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

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

What is research?
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalisable knowledge

Clinical audit
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 vs clinical audit Research asks ³What¶s the right thing to do?´ Audit asks ³It is done right?´ .

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

NIH definition of Clinical Research Patient-oriented research includes: a)Mechanisms of human disease. c) Clinical trials. e)Epidemiologic and behavioral studies. and f) Outcomes research and health services research. b)Therapeutic interventions. d)Development of new technologies. .

or Identifiable private information .Definition of human subject Human subject means a living individual about whom an investigator conducting research obtains Data through intervention or interaction with the individual.

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 .

Initiatives to develop 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 .

NATIONAL INSTITUTES OF HEALTH Institute of Public Health (IPH) Clinical Research Centre (CRC) Institute of Health Promotion (IHP) Institute of Health Management (IHM) Institute for Health System Research (IHSR) Institute for Medical Research (IMR) National Institute For Natural Products and Vaccinology (9Bio) .

Objective of NIH 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 .

academia and pharmaceutical industries To establish policy and plan clinical research To improve infrastructure .National Committee for Clinical Research A steering committee for clinical research was established in 1997 To coordinate and promote clinical research Enhancing clinical research through collaboration between MOH.

Malaysian GCP guideline .

9th MP: Health research priorities 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 .

National Biotechnology Policy 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. .

Role of Biotechcorp 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 .

CWG on Healthcare Biotechnology 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 .

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 allowance Bionexus status IT exemption .

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 .

New drug development & Clinical trials.. .

W. Grabowski HG.And it is hugely costly«. Ref: DiMasi a JA. The price of innovation: new estimates of drug development costs Journal of Health Economics 22 (2003) 151±185 . Hansen RW.

´ Tufts Outlook 2007 Report. up to 65% of FDA regulated clinical trials for top pharmaceutical companies will be conducted abroad.The Clinical Research Industry 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. 3 January 2007 . including Asia ³Within two to three years.

MIT Center for Biomedical Innovation.5% -6. Berndt. Nov 2007 . Thiers. Anthony J.8% 3.9% Ref: Fabio A.Clinical trial market growth rate Region East Europe Asia Latin America West Europe North America Average relative annual growth rate 24% 20. Sinskey and Ernst R.4% 19.

Korea Taiwan Japan Australia Singapore N.2 0.6 0.0 0.7 1.1 7.2 ARAGR 47.9 26.1 0. Zealand Sites 533 161 178 111 133 757 466 420 2002 1131 86 138 Shares 0.0 32.7 0. Kong Thailand India S.9 10.1 30.Asian Top 12 Fastest Growing Clinical Trial Market Ranking 1 2 3 4 5 6 7 27 9 10 11 12 Country China Malaysia Philippines H.2 1.6 2.3 8.4 19.9 13.5 0.2 0.1 0.1 5.9 Global Ranking 1 5 8 13 14 20 23 27 31 34 36 37 Trials beginning 2002-2006 .5 26.6 17.

of clinical trials conducted in Malaysia 7 4 7 8 4 7 Source: National Pharmaceutical Control Bureau.No. of applications for the clinical trial import license for unregistered products. . No.

Malaysia as a clinical trial hub Network of CRC launched in April 2007 One-stop centre to promote Malaysia as a preferred clinical trial site .

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Network of CRCs. MOH .

SMO function of the OSC 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 .

Clinical Trials Clinical Trials Captured on NMRR (259) Sponsorship Industry Sponsored Investigator Initiated Not Available Total 200 23 72 0 95 200 55 105 4 16 .

identify and recruit suitable investigators feasibility assessment for trial proposal submitted by industry .One stop-centre first line of contact for industry.

One stop-centre assist with ethics & regulatory submissions pre-screening of patients at non-participating sites for enrollment into trial establish and update Investigator Database .

Feasibility Study Performance 2007 Total Number of Feasibility Studies Total Number of Investigators Approached Total Number of Clients Served Average Number of Investigators Approached / Assignment Average Number of Responses / Assignment Average Number of Positive Responses / Assignment 43 733 15 17 12 5 2008 (till September) 83 1545 23 19 13 5 Total No of Feasibilities : 126 .

Feasibility : Therapeutic Areas Highest No of Feasibility Assignments According to Therapeutic Area 200 Cardiology : 8 Medicine : 6 Oncology : 5 Nephrology : 4 200 Oncology : 18 Psychiatry : 12 DM : 8 Nephrology : 7 .

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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Reasons for trial registration 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 .

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g 25 .Parameter Response Published Number needed Yes NNB 10 95% CI 5-g SAE Yes NNH g NNH 50 34 .g to NNB 100 Suicidal ideation Yes & attempts .

Parameter Response Remission SAE Published Number needed Yes No Yes NNB 10 NNB 34 NNH g NNH 50 95% CI 5-g 5 .g to NNB 100 Suicidal ideation Yes & attempts .g to NNH 8 34 .g 25 .

Reasons for trial registration 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 .

2005 Nov. .Trial Registration Protocol Items proposed by pharmaceutical industry.2(11):e378. the WHO and the Ottawa Group PLoS Med.

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clinicaltrials.gov www.au www.ICMJE accepted registries ClinicalTrials.nl .umin.ac.anzctr.org www.org UMIN Clinical Trials Registry (UMINCTR) The Netherlands National Trial Register (NTR) www.trialregister.jp www.gov Australian New Zealand Clinical Trials Registry (ANZCTR) ISRCTN.isrctn.org.

gov.nmrr.National Medical Research Register https://www.my .

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 .NIH Policy Statement All research require prior registration with and approval by the MOH.

New User Registration .

Registration of new research .

Research database .

Research database .

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 .

Funding for 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 .

MOSTI grant Science Fund supports basic and applied science research biotechnology is supported TechnoFund commercialization of research .

etc Private industry multinational pharmaceutical companies Universities . Professional Organizations/NGOs MAKNA.Funding for Clinical Research International Agencies WHO/WPRO/SEAMO-TROPMED etc.

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 .

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

Conclusions 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 .

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