research ethics review malaysian experince dato dr. zaki morad. chairperson mrec dr. lim to. member...
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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