Professor Dr. Abdul Rashid is one of the pioneering Clinician Scientist in Malaysia. He was trained in both Internal Medicine and Clinical Pharmacology in the United Kingdom. He pioneered the establishment of the Clinical Trial Unit at USM Kota Bharu, the Advance Medical and Dental Institute at USM Penang and the Clinical Trial Center in Cyberjaya University College of Medical Sciences. He is also a pioneering member of the National Committee of Clinical Research and the Chairman of the Malaysian GCP Guideline. Prof Rashid is currently Medical Director and Consultant Physician at An Nur Specialist Hospital, Visiting Professor to a few universities and a Visiting Consultant for clinical research at the National Heart Institute.
Prof Rashid, as an experienced clinician scientist in early phase clinical trials, how important is early phase studies to the medical world?
It is crucial! Ibn Sina (Avicenna) more than a millennium ago outlined 7 principles to determine whether a treatment works. One of the principles is that if it works in animals, it does not necessary mean it works in human. Ibn Sina is the true father of Modern Medicine and Evidence Based Medicine!
How do you think Malaysia can benefit from conducting early phase studies?
When we started in the late 80s and early 90s, we were only doing ‘clinical trials’ on marketed drugs because the industry wants our doctors to get use to the drugs and then use it in our daily practice. In the late 90s onwards especially when we launched our GCP Guideline (1999) and then made it compulsory for clinical researchers (early 2000s), phase 2 and 3 trials came flooding to our shores. I clearly remembered giving a talk on Malaysia’s 10 years’ experience on GCP Training and was informed by a representative from a multinational company that Malaysia is not ready for Phase 1 trial yet. This was in October 2008. I felt at that time that we as a nation were being challenged! If and when we are acknowledged to be capable of conducting Phase 1 trials, it will be a testimony that we have made it in terms of completing the ecosystem for clinical trials. To me personally we should not be contented to perform contract research even at Phase 1 level. Our involvement in Phase 1 contract research should be a fore runner for our own initiative to discover new drugs. We have a sizeable number of scientists doing basic drug research on animals. We have clinical trialists with vast experience in phase 2 and 3 trials. Developing capacity for phase 1/First in Man trial will be icing on the cake.
I dream of a discovered-in-Malaysia product which has been researched in Malaysia from pre-clinical right through to phase 3 trials.
Do you think that Malaysia is ready to embark on conducting early phase studies (ie. First in Man) and why?
Not yet but we are taking the right steps. To me the critical success factor will be the ‘software’ not the ‘hardware’. By that I mean the human capital. We need to bridge the gap between the current expertise we have in animal research and middle (Phase 2 and 3) to late (Phase 4) phase clinical trials. We need to have a critical mass of clinical pharmacologists, clinical toxicologists, clinical trial methodologists and translational researchers.
In your opinion, why is it important for the Ministry of Health, institutions and the universities to work collaboratively towards developing a complete ecosystem in clinical research?
I see this already happening partly by design. I was personally involved as Chairman of the Health Cluster for the now defunct Intensification of Research in Priority Area (IRPA) where we insisted that researchers must show evidence of collaboration with other researchers especially when they apply for big grants in the Prioritised Research category. Malaysia is a small nation with an even smaller researcher community especially in clinical research. It is thus crucial that clinical researchers collaborate to avoid missed opportunities and unnecessary duplications in redundancies. When it comes to health research, the MOH, being the ultimate guardian and biggest stake holder must obviously take the lead so that research done will be focused to the national health agenda and needs.
In the field of clinical research, where do you wish to see Malaysia in the next 10 years?
For clinical research as a whole, I dream of a major trial initiated and conducted in Malaysia which will change clinical practice and quoted in Clinical Practice Guidelines, not just locally but internationally. Thailand and Vietnam have done it. Why can’t we? To do that we have to be focused and galvanise our expertise collectively. For drug development, I dream of a discovered-in-Malaysia product which has been researched in Malaysia from pre-clinical right through to phase 3 trials. Hopeful it becomes a best seller too! Expertise in Phase 1 trial is currently among our weakest links. That needs to be addressed sooner rather than later.