1. Research Ethics Review Malaysian experince Dato Dr. Zaki Morad. Chairperson MREC Dr. Lim TO. Member MREC MOH Malaysia

2. Contents 1.Background: Clinical trials in M’sia 2.Oversight of Research Ethics in MOH/Malaysia

3. Industry sponsored Trials in Malaysia

4. 1.Chemotherapeutics- antibacterial,antifungals,antivirals 2.CNS drugs- antidepressants,antiepileptics,antips ychotics, dementia 3.Musculoskeletal & Joint disease& analgesia 4.Hematopoietic System/Blood Disorders 5.Cardiovascular systems 6.Anticancer 7.Agents Affecting Bone Metabolism 8.Genito-urinary disorders 9.Antidiabetics 10.GIT disorders 11.Vaccines 12.Lipid Lowering 13.Respiratory disorders 14.Others : anabolic agents, anesthesia, contraceptives, dietary supplements, appetite suppressants, immune suppressors, corticosteroids, obstetrics, eye preparations No. of CTs Conducted by Therapeutic Class (Year 1998-2004)

5. Ensuring Ethical Research: A joint responsibility Investigative sites supported by dedicated Research Organization Sponsors willing to play by the rules IEC/IRB with dedicated Admin support Regulatory Authority willing to enforce the rules NCCR

6. 1. Investigative sites & Research organization This is where the action is; where investigators enroll patients into the trial Ethical trial conduct & compliance requires: Adequate resources to conduct the trial Training, eg GCP certification Independent monitoring of trial conduct etc Sites therefore must be ably supported, this is provided by dedicated research organization such as Clinical Research Centre (CRC)

7. 2. Sponsors These “pay” for the research Mostly industry sponsors (mostly drug trials) or government grant agency (eg NIH of the MOH, MOSTE) Independent monitoring /audit by sponsors: common practice for industry, grant agency still lacking Sponsors certainly could do more: Efficiency vs Ethics

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

9. 3. IEC/ IRB “An independent body constituted of medical professionals and non-medical members whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.” ICH GCP 1.27 In Malaysia, for MOH/private sites, this is the Medical Research & Ethics Committee of the MOH (MREC); universities have their own IECs. Usual problem being inadequate admin support and resources

10. MREC To conduct scientific and ethical assessment of all health research conducted by the Ministry of Health (MOH) researchers and non-MOH researchers utilizing facilities and resources of the MOH The MREC is directly responsible and operates under the authority of the Director-General of Health, Malaysia Operates in accordance to the ICH GCP Guidelines

11. 4. Regulatory Authority This is the Drug Control Authority (DCA) DCA has a broad public protection mission to ensure the safe use of regulated products that are themselves safe and efficacious Ensure Implementation of trial related guidelinesa nd legislation

12. Guidelines and Legal Requirements Guidelines: Malaysian Guidelines for GCP (Updated 2004) Guidelines for Application to Conduct Drug-Related Clinical Trials in Malaysia( 2nd edition) Guidelines for Application of CTIL and CTX in Malaysia Laws Control of Drugs and Cosmetics Regulation 1984 The Poison Regulation (Psychotropic Substances) 1989 Sale of Drugs Act 1952 Weakness - No legal provisions addressing the Conduct of Clinical Trial; administrative provisions through Guidelines Malaysia GCP Guidelines “5.20.3 The DCA will enforce the rules and punitive action will be decided by the DCA “

13. 5. National Committee for Clinical Research(NCCR) Forum for dialogue among all parties: Regulatory authority, IECs, Sponsors, Investigators from MOH/Universities/ Private hospitals Promulgate & implement various guidelines: - GCP, Bioequivalence (BE) studies, GLP, Guidelines for Application to Conduct Drug-Related Clinical Trials in Malaysia, Guidelines for Application For CTIL/ CTX etc Oversight for training on GCP Site-inspection for clinical trials Review processes for approval of clinical trials

14. www.crc.gov.my