Research Ethics ReviewMalaysian experince

Dato Dr. Zaki Morad. Chairperson MREC Dato Dr. Zaki Morad. Chairperson MREC Dr. Lim TO. Member MRECDr. Lim TO. Member MREC

MOH MalaysiaMOH Malaysia

Contents

1. Background: Clinical trials in M’sia

2. Oversight of Research Ethics in MOH/Malaysia

Industry sponsored Trials in Malaysia

PHASES OF CLINICAL TRIALS CONDUCTED IN MALAYSIA

(excluding Bioequivalence Studies)

0

510

15

20

2530

35

40

1996 1997 1998 1999 2000 2001 2002 2003 2004

Phase I

Phase II

Phase III

Phase IV

1. Chemotherapeutics- antibacterial,antifungals,antivirals

2. CNS drugs-antidepressants,antiepileptics,antipsychotics, 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)

0

5

10

15

20

25

30

35

40

45

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Therapeutic Class

No. o

f Clin

ical

Tria

ls

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

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 certificationIndependent monitoring of trial conductetc

Sites therefore must be ably supported, this is provided by dedicated research organization such as Clinical Research Centre (CRC)

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

NATIONAL INSTITUTE OF HEALTH, MALAYSIA

Institute forMedicalResearch

(IMR)

Institute ofPublic 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

OFHEALTH

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 1.27In 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

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

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

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

LawsControl of Drugs and Cosmetics Regulation 1984The Poison Regulation (Psychotropic Substances) 1989Sale 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 “

5. National Committee for Clinical Research(NCCR)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

www.crc.gov.my