Dr Goh Pik Pin

24/6/2013

Sibu Research Seminar 2013 1

Role of CRC and CRM in

clinical research

Goh Pik Pin

Clinical Research Centre

MOH

1

Scope of presentation

Messages from Director General ofhealth

Research in MOH-NIH Guideline

NMRR registration

The network of CRC

Role of CRC national

Role of CRC Hospital

Role of Clinical Research Malaysia

Research in MOH

3

Messages from DG Datuk Dr. Noor Hisham

Good quality service and research is the order of the

day. We must be driven by curiosity, we must

cultivate passion for answers and challenging

current practices and provocation thoughts for a

better tomorrow with ideas of innovation and

change. More importantly we need good

transformational leaderships.

Go for it.

Hisham

From DG Datuk Noor Hisham

If you don’t count, you don’t count

If you do not publish, you do not exist

Need evidence for improving in

healthcare

Engage patients as partner to improve

healthcare service

Research Institutes at MOH

IMR - Biomedical Research

IPH - Epidemiological Survey Research

CRC - Clinical Research-research on human

IHM - Health Management

IHSR - Health Policy and Systems Research

IHBR - Behavioural Research

Dr Goh Pik Pin

24/6/2013

Sibu Research Seminar 2013 2

Guidelines on research conducted at MOH

NIH Guidelines

1. Research involves MOH personnel, conducted at MOH facility

OR funded by MOH research grant need to be registered to

NMRR

2. Research involving human subjects requires prior review and

approval by Medical Research and Ethics Committee (MREC)

3. Publications, whether in the form of research report, journal article

or conference proceeding need approval from Deputy Director

General Research and Technical Support

Principles

Research conduct to be adhered to Good Clinical (Research)

Practice

Principal Investigator and Co-Investigator of interventional

study/ trials need to have GCP certification

Drug trial– Clinical Trial Import License (CTIL) fr NPCB or BPFK

The Network of Clinical Research Centre

Conceived in the 1990s as the clinical research arm

of the MOH; first centre opened in HKL in 2000

By 2011, the Network of CRCs comprises 27 centres

in MOH hospitals at all the 14 states and one Early

phase clinical trial unit at Ampang Hospital

Network of CRC - 27 Hospital CRCs & A Phase I Clinical Trial Unit

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National and 22 Hospital CRC 1 CRC, Tuanku Fauziah Kangar Perlis

2 CRC , Sultanah Bahiyah Kedah

3 CRC, Hospital Pulau Pinang

4 CRC, Hospital Seberang Jaya

5 CRC, Hospital Raja Permaisuri Bainun Ipoh

6 CRC, Hospital Taiping

7 CRC Hospital Sri Manjung

8 CRC, Hospital Selayang

9 CRC, Hospital Serdang

10 CRC, Hospital Tuanku Ampuan Rahimah Klang

11 CRC Hosp Ampang

12 CRC Hkl

13 CRC, Sungai Buloh

14 CRC, Hospital Putrajaya

15 CRC, Hospital Tuanku Jaafar Negeri Sembilan

16 CRC, Hospital Melaka

17 CRC, Hospital Sultanah Aminah Johor Bahru

18 CRC, Hospital Sultan Ismail Johor Bharu

19 CRC, Hospital Tengku Ampuan Afzan Kuantan

Pahang

20 CRC, Hospital Nur Zahirah Kuala Terengganu

21 CRC, Hospital Perempuan Zainab Ii Kelantan

22 CRC, Hospital Queen Elizabeth 1 Sabah

23 CRC, Hospital Queen Elizabeth 2 Sabah

24 CRC, Hospital Likas Sabah

25 CRC, Hospital Umum Sarawak

26 CRC, Hospital Miri

27 CRC,Hospital Sibu

Financial &Technical Human Resource & physical space

Dr Goh Pik Pin

24/6/2013

Sibu Research Seminar 2013 3

CRC’s Vision and Mission

Vision : To become a leading clinical research

institution in Asia

Mission : To improve patients’ health outcomes

through ethical and quality clinical

research

Key tasks are to develop

- - Capacities among MOH staff to conduct high quality and

ethical clinical research

- - Network of healthcare facilities with access of a large pool

of investigators & patients for research

So What Does CRC Do?

1. Develop Research Capacity

2. Develop

Data Resources

3. Promote & Monitor

Contract Research

4. Support Investigator

Initiated Research

5.Publication

Five Inter-related Tasks

Functions of National CRC

To provide leadership in the development and

strengthening of clinical research capacity in the

Ministry of Health

To facilitate the establishment of hospital clinical

research centres and provide technical support to the

network of HCRCs

To promote and support the conduct of Investigator

Initiated Research among Ministry of Health staff

Functions of National CRC - Contd

To coordinate the conduct of Industry Initiated

Research at MOH facilities

To establish and maintain clinical data base for the

Ministry of Health

To establish collaboration with local, regional and

international research organisations in the pursuit for

excellence in clinical research in the country

Functions of Hospital CRC (HCRC)

1. To Support And Facilitate Research Activities In

The Hospital Through The Provision Of:

a) Database of clinicians interested in research – interest

areas, track record on ISR / IIR and publications

b) Technical support such as statistical analysis

c) Administrative support such as research assistant and

study coordinator

d) Facility support such as IT, statistical software and

others

Functions of HCRC - contd

2.To assist in the registration of research protocol to

National Medical Research Register (NMRR) and

application of grants for research

3. To participate in clinical trials and other research

initiated or coordinated by the national CRC

4.To promote research through capacity building in the

following ways:

a)Conduct courses like Good Clinical Practice

(GCP), Good Research Practice (GRP), Research

Methodology and Statistics

Dr Goh Pik Pin

24/6/2013

Sibu Research Seminar 2013 4

Functions of HCRC - contd

b) Conduct regular in-house CPD

c) Conduct Research clinics – consultation on

research methodology, study design, protocol

and statistical analysis

d) Mentoring programme for clinicians and other

medical professionals interested in research CLINICAL RESEARCH

MALAYSIA

Economic Transformation Program- 12

New Key Economic Areas (NKEA)

Research that generate wealth to country

Tap larger pool of patients

Grow number of contract research org and improve site management

Restructure MOH's One-Stop Centre (OSC-CRC) to CRM

Clinical Trials 1000 / yr by 2020

Increase sites: MOH/ Uni/ Private

Facilitate bioavailability & bioequivalence development

Grow Malaysia's

Clinical Research Ecosystem

Grow pool of investigators, site coordinators

Expand scope of trials: Early Phases, Stem Cell, traditional medicine, Genomics

Build Malaysia's reputation as the preferred clinical trial destination

Optimise ethics and regulatory processes

Attract more international and local sponsors

CRM was corporatised on 18st June 2012.

The Board of Directors will have at least one

representative from the Ministry of Health

Chairman of BOD

1)YB Health Minister

Directors of the Board

2) Director General of Health

3) Dato’ Dr Zaki Morad

4) Director of the Network of CRC

5) Prof Dr. Sim KH

CRM, a corporatised not for profit entity,

that is owned by the government

Dr Goh Pik Pin

24/6/2013

Sibu Research Seminar 2013 5

CRM’s Objectives

To accelerate the growth of industrial sponsored clinical trials

& clinical trial sites by promoting & marketing Malaysia as a

trial hub.

• To collaborate with stakeholders in developing, expanding and

strengthening the research industry in Malaysia

• To facilitate industry in the selection of Ministry of Health

facilities to conduct contract research.

• To support investigators in managing and conducting quality

clinical trials in the Ministry of Health Malaysia (MOH)

facilities.

Objectives of CRM CRM Functions-1

One Stop Service

To be the centre of information

To assist industry in identifying investigators and trial sites

To assist principal investigators in the conduct of feasibility assessment , trial

and budget negotiation with sponsors

To review Clinical Trial Agreements and provide legal assistance for

investigators

To provide link-up with local and international Contract Research

Organisations

To provide oversight in the conduct of industry sponsored research in Ministry

Of Health (MOH) facilities

To manage research funds for MOH sites

CRM Functions-2

Capacity Development

To train investigators

To train research assistants and research nurses.

Marketing and Promotional Activities

To host conferences

To host meetings and dialogues with industry

To speak and exhibit in local and international

CRM - manage research funds for MOH

sites

Sponsor

/ CRO

CRM – as the

payee in CTA

Investigator

CRC – Clinical

Research Trust

Account

Enters into

CTA

Payment to

Invoice to

Process &

issue

payment to

Process payment

via EFT to

MOH policy

1. ISR as urusan rasmi

2. Attending investigator meeting abroad

MOH policy

–fees payment to MoH Staff

Dr Goh Pik Pin

24/6/2013

Sibu Research Seminar 2013 6

Respond to feasibility studies

Bring your ISR problems to the HCRC team for assistance

Participate in quality ISR

Support and train the next generation of PIs

Give constructive feedback to CRC and CRM to improve the

conduct of ISR in the country

How Can You Contribute To The Country’s

Agenda?

32

Malaysia as preferred clinical trial destination in Asia

END