As part of the Economic Transformation Programme, clinical research is one of the entry-point project (EPP) for healthcare; and 2011 will bring a string of changes to this industry. The aim is to create a supportive and complete ecosystem to increase the number of trials in Malaysia. One major transformation will be the setting up of Clinical Research Malaysia (CRM), a not-for-profit government site management organisation which will be the gateway to Malaysia's clinical research industry.

Why the need for CRM?

The global contract research industry has grown 15% to reach more than $20 billion in 2009, and Asia has outpaced the global market with an annual ~30% growth to reach ~$ 1.6 billion. But Malaysia’s performance has lagged behind its Asian peers, with annual growth of 7–8% (2003–2009) and may also have reached a plateau.

How will CRM help make Malaysia the new preferred clinical trial destination in Malaysia?

1) It will transform the industry by creating a supportive ecosystem to grow the number of new trials.

2) It will build Malaysia’s reputation for speed and quality by streamlining and strengthening ethical and governance processes.

3) It will promote centres of excellence that emphasise service, research and teaching.

4) It will build on the strengths of Ministry of Health’s integrated network and information system.

5) It will galvanise local investigators/sites, enhance their capability with training and increased support.

Services provided by CRM

1} One-stop SERVICE:

1.1) As a centre of information

1.2) Assist industry in identifying potential investigators and sites

1.3) Assist in conducting feasibility assessment on PI’s behalf

1.4) Trial negotiations with sponsors on behalf of PI

1.5) Review CTA, provide legal assistance and assist with budget negotiations

1.6) Management of research fund for MOH sites

1.7) Provide link-up with local and international CROs

1.8) Provide oversight on the conduct of contract research in Ministry of Health facilities

2) Capacity development

2.1) Train investigators

2.2) Train research assistants and research nurses

3) Marketing & promotional activities

3.1) Host conferences

3.2) Host meetings and dialogues with industry

3.3) Speak and exhibit in local, regional & international conferences

Image reproduced with permission. Source: Economic Transformation Programme: A Roadmap for Malaysia

How does clinical research benefit the country?

1. Patients access to novel treatments that are not yet available

• Access for patients who could not otherwise afford treatment.
• Assess to novel treatments when existing options have been exhausted.
• Create a collaborative and supportive investigator-patient environment.

2. Increase knowledge of medical practitioners

• Keep up-to-date with latest medical advances to improve quality of care.
• Collaborate with international clinicians in global trials.
• Gain confidence from experience in testing new drugs and treatments.

3. Build innovation capability for local industry

• Develop local Clinical Research Organisations (CROs) into internationally competitive players.
• Create R&D capabilities in biopharmaceutical, biotech, medtech and Traditional Chinese Medicine (TCM).
• Stimulate the establishment of Good Laboratory Practice (GLP) certified laboratories.
• Build know-how to tap Malaysia’s bio-diversity.

4. Increase publication quality and volume by Malaysian investigators

• Solidify Malaysia’s position as a healthcare knowledge hub.
• Build up pool of key opinion leaders.
• Create stimulating and supportive environment for promising doctors, reversing brain drain.

Some of the above content is courtesy of The Performance Management & Delivery Unit (PEMANDU).

For more details, refer to

1. Contract Research in Malaysia

2. Economic Transformation Programme: A Roadmap for Malaysia: Chapter 16 (Creating Wealth through Excellence in Healthcare).

or send your enquiries to:

Dr Thevendran Sadasivam

Clinical Research Centre (One Stop Centre)
Level 3 Dermatology Block Kuala Lumpur Hospital
Jalan Pahang, 50586
Kuala Lumpur, MALAYSIA
Phone: +603 2692 4249/ +603 2691 1486/        +603 2698 0310 
Fax: +603 2691 1682
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Website: www.crc.gov.my

Related articles

Contract Research at MOH Hospitals. Berita MMA 2011(January):17-18

Industry-Sponsored Clinical Research in Malaysia: New Chapter in 2011. National Committee for Clinical Research Bulletin 2010(2):3-4

A Case Study: Refining Clinical Research Infrastructure. Clinical Trial Magnifier 2010;3:203-218 (full article available at http://www.magctc.com/archive.aspx with free registration)