Transcript Clinical Research in Malaysia

Research Ethics Review
Malaysian experince
Dato Dr. Zaki Morad. Chairperson MREC
Dr. Lim TO. Member MREC
MOH 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)
40
35
30
25
20
15
10
5
0
Phase I
Phase II
Phase III
Phase IV
1996 1997 1998 1999 2000 2001 2002 2003 2004
No. of CTs Conducted by Therapeutic Class (Year 1998-2004)
1.
Chemotherapeuticsantibacterial,antifungals,antivirals
2.
CNS drugsantidepressants,antiepileptics,antips
ychotics, dementia
3.
Musculoskeletal & Joint disease&
analgesia
4.
Hematopoietic System/Blood
Disorders
5.
Cardiovascular systems
6.
Anticancer
20
7.
Agents Affecting Bone Metabolism
15
8.
Genito-urinary disorders
9.
Antidiabetics
10
10.
GIT disorders
5
11.
Vaccines
12.
Lipid Lowering
13.
Respiratory disorders
14.
Others : anabolic agents, anesthesia,
contraceptives, dietary supplements,
appetite suppressants, immune
suppressors, corticosteroids,
obstetrics, eye preparations
45
40
No. of Clinical Trials
35
30
25
0
1
2
3
4
5
6
7
8
9 10 11 12 13 14
Therapeutic Class
Ensuring Ethical Research:
A joint responsibility
Investigative sites
supported by
dedicated
Research
Organization
Sponsors willing to
play by the rules
NCCR
IEC/IRB with
dedicated Admin
support
Regulatory
Authority willing to
enforce the rules
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)
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
NATIONAL
INSTITUTES
OF
HEALTH
Institute of
Public
Health
(IPH)
Institute for
Medical
Research
(IMR)
Clinical
Research
Centre
(CRC)
Institute of
Health
Management
(IHM)
Institute of
Health
Promotion
(IHP)
Institute for
Health System
Research (IHSR)
National Institute
For Natural
Products and
Vaccinology
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
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
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 “
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