Establish Clinical Research Centre as National

Focal Point for Clinical Research in MOH

-sharing from Malaysian MOH

Dr. Goh Pik Pin, MD,

MS(Ophthal),MPH
Director, CRC Network
Director, CRM
Malaysia & Indonesia
• Area- 6x smaller
• Population- 31m vs. 255m
• Majority young population
• Multiracial
• Similar top causes of death
• CHD, Stroke, Influenza/Pneumonia, Lung
disease, MVA,DM
• Life style risk - smoking , obesity, (not
alcohol)
• Health expenditure-4.5% vs. 3 %GDP
• Thread- rising health care cost, aging
population 2
2010- Healthcare Facilities & Workers in Malaysia
Public Hospitals Malaysia Ratio
MOH-137
University-3

Private Hospitals Doctor 1: 859

217
Dentist 1:7347
Health Clinics
MOH -2833 Pharmacist 1: 3625
Dental Clinics
MOH-34
Private-1512 Private Clinics Nurses 1:410
6442
Out patients visitsPublic-49 millions
Private -3 million
NIH (Research Hospital admission Public-2 million
Institute) :6 Private- 870,000

Manpower and Materials for Research

Cost centre- spend money
 Clinical Research- an essence in medical
progress
Translational research – from scientific discoveries into
clinical practice to benefit human

Basic Science Biomedical Clinical Science Clinical Clinical Practice

research Research

Translation from Translation of

basic science to research findings
studies on human into clinical practice
to improve patients’
care
 Clinical Research has 2 targets:

1 Better Health of the people

Generate wealth for the

2 nation- $
 Clinical Research Framework and Outcome
Clinical Research Ecosystem: strengthening the ...to drive key ...that create positive
pillars within a supportive framework ... success factors ... outcomes

1
Governance Social and economic
2 Scope of trials impact

Patient Innovation
Human access capabilities
3 Process Resource
capital
Publications
Physician and
Speed capabilitiesreputation
4 Organisation
5 Research culture Time
Study Subjects
Data Management

Safety
Lab
Surveillance
Enrollment
Coordinator
Scheduling

Monitors

Investigator/ study coordinator

/ pharmacist at Study Sites Regulators/ ethics
Clinical Supplies

The design and conduct of modern clinical research is a complex undertaking, requires many
professionals from diverse disciplines to perform the variety of work processes.
But the process is also most regulated
 1. Public Health
Ministry of Health- Organisation Chart 2. Medical
3. Research
4. Dental
5. Pharmacy
6. Food Safety & Quality

1 2 3 4 5 6

NIH

IMR IHSR IPH IHM CRC IHM

 Clinical Research Centre
established year 2000
Our Vision Our Mission

To be leading clinical To Improve patients’ health

research organization outcomes through ethical
and quality clinical research
in Asia
 So What Does CRC Do?
Five Inter-related Tasks
1. Develop Research Capacity

2. Develop
Data Resources
3. Promote & Monitor
Contract Research

4. Support Investigator
Initiated Research

5.Publication
 CRC Organisation Chart

Director
Administration
ICT Unit
& Finance Unit
Clinical Clinical Quality Network
Epidemiology Healthcare Trial of
Assurance
Unit Statistics Unit Unit 33 CRC
Unit
Hospital
s
Biostatistics
 Network of CRC
- 33 Hospital CRCs & Early Phase Clinical Trial Unit
*
*
* *
* *
* * *
* *
* *
*
* **
*
**
* *
** *
*
* * *
* * *
 The Network of Clinical Research Centre (CRC)
Key task: enhance capacities to Key task: Prepare study sites with
enable high quality and ethical investigators & patients for research
clinical research

1. Training-research 1. Network of CRCs comprises

methodology, GCP etc. CRC units in 33 MOH
hospitals
2. Consultation-study 2. Engage young MOH staff
protocol, statistical analysis on career path in research
3. Identify specialists to be
3. Promotion- research camp,, mentor
state research day 4. Public education through
social media
4. Awareness on guideline
and regulation on research

5. Conduct audit at CRC

hospital
Hospital CRC Set Up

 Physical
 Human Resource
Hospital CRC Set Up
Physical Infrastructure :
– CRC Office (work station, meeting room, computer, internet, fax & international phone line, server)
– Clinical Trial Clinics- bed, BP set, ECG
– Procedure room with lab equipment-centrifuge
– Investigational product storage – cupboard, fridge
– Document archives
• ±Clinical Trial Ward(early phase trial)

CRC Office Centrifuge & Freezer IP Room

Hospital CRC Set Up
Human Resource
• Need of following MOH staff • Need from CRM corporate
A. Technical 1. Lawyer- review clinical trial
agreement
1. Medical Officer
2. Study subject recruiter – healthy
2. Pharmacist
volunteers
3. Nurses-Study coordinator
3. Expert in feasibility study
4. Research Officer
4. Finance manager –trial budget
5. Statistician
B. Admin
1. Administrator /clerk
How to Achieve the Targets ?
- Four Pillars at CRC Hospital

A. Research
B. Training
C. Consultation
D. Management
Output of Research : Reports/Publication

# ISR(All) ISR in MOH

250
195 202 201
200 179
National Investigator 157
150 128
Surveys- Initiated 101
125

Medicines Use /Industry 100

Medical Device Sponsored 50
& Primary Care Research
0
yr2011 yr2012 yr2013 yr2014 yr 2015

160
National 145
140
Healthcare 126
120
Establishment Publication 106
97
100
& Workforce
80
Surveys
60
40
20
0
yr 2012 yr2013 yr2014 yr2015
Barriers To Conducting Research- Survey on MOH Specialists
Turning Point - Clinical Research becomes
National Agenda
1. Vision 2020- 6th Malaysian plan (1991-1996)
2. Industrial Master Plan (2006-2020 )
3. 10th Malaysian Plan (2011-2015)
4. Economic Transformation Program (2010- 2020 )
5. NKEA-EPP2 Clinical Research Malaysia(2010 -2020 )
• wwww.pemandu.gov.my
• www.clinicalresearch..my
6. 11st Malaysian Plan (2016-2020)
Economic Transformation Program-
12 National Key Economic Areas (NKEA)
Clinical
Research M’sia
 NKEA: Healthcare
Clinical Research Malaysia

Creating a supportive environment and complete

ecosystem to grow number of clinical trials

Target 1,000 clinical trials by 2020 RM578.4 1000

million
High
GNI
Skilled
Impact
Jobs
CRM- develop a supportive clinical research ecosystem
Collaboration
with universities
 CRC Network Meeting
National Conference for Clinical Research
Thank you for your support
• Get in touch
contact @crc.gov.my

www.crc.gov.my
A. Research
1. Research ideas
1. Policy driven- Zika, Dengue, Hepatitis C, Cancer, DM
2. Gaps in clinical practice -TB
3. Post-graduate students/ specialists in training
4. Contract or Industry Sponsored Research (ISR)
2. CRC staff conduct or support other MOH staff
1. Protocol development
2. Project management
3. Data management – data entry and statistical analysis
B. Training
1. Training own HCRC staff
– Required training based on years of service in
CRC
2. Training other MOH staff
– Organise essential training on research
– GCP, research method, statistic ,etc.
C. Consultation
1. Research consultation clinic
1. Protocol development – sample size, statistical test
2. Statistical analysis
3. NMRR registration /IAHOD form
4. MRG application
2. MOH staff become key opinion leaders or subject
matter expert and be international consultants -
invited speakers, journal reviewers/editors
D. Management
1. Financial management – operating budget, asset
2. Human resource –performance appraisal
3. Research committee
– Hospital level
– State research committee
4. Promotional activities
– Hospital research day
– State research day
– National Clinical Research Conference
But…How to sustain the flame