Malaysia may soon become a favored destination for clinical trials in the Asian region and can emerge as a possible competitor to India in clinical research in future, according to Prof Dixon Thomas, HoD of Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur in Andhra Pradesh.
Prof Dixon Thomas is doing a research on the project Clinical Research Malaysia (CRM) launched by Malaysian government as part of the country’s Economic Transformation Programme (ETP). The ETP includes 12 national key economic areas (NKEA) which included clinical research. In view of the potential foreign investment to the country, contract clinical research has been identified as one of the entry point projects for the NKEA.
In a chat with Pharmabiz, Prof Dixon Thomas said Asia has 80 per cent of the world population and Malaysia being a country within the ASEAN region, is well-placed to achieve the status of a preferred destination for clinical trials in the region. Coordination of public and private hospitals, clinical research organizations, diverse patient pool, low cost and qualified professionals are the supporting factors that help the country to achieve that goal. The population in the ASEAN region provides huge potential both for the scientific pursuit of clinical trials as well as the subsequent pharmaceutical commercialization of research & development efforts.
According to him Clinical Research Malaysia is a project established to promote and develop the growth of industry sponsored clinical trials. Its main task is to encourage and support the pharmaceutical industry and clinical research organizations to select Malaysia as the preferred destination for contract clinical research and thus gain foreign direct investment from the global drug development industry. Its core function is to coordinate and foster greater collaboration among the ministry of health’s network of 24 Clinical Research Centres (CRCs) and other independent CR centres formed in private hospitals and academic centres, he said.
Regarding the progress of the project, he said Malaysia has made efforts in increasing the number of high-quality clinical trials being conducted by initially forming a One-Stop-Centre within the CRC, which acts as the main contact point for network of CRCs to facilitate access to 137 general and district Ministry of Health (MOH) hospitals. These hospitals act as the referral center for more than 4000 health clinics serving as potential sites for clinical trials. This One-Stop-Centre serves as the main contact point for industry and sponsors to access the sites and investigators. The Health Minister of the country, Datuk Seri Liow Tiong Lai, during the opening ceremony of National Conference for Clinical Research 2011, launched Clinical Research Malaysia (CRM) and announced that CRM would provide a unique strategy to attract clinical trials to Malaysia, Prof Thomas added.
When asked about the advantages of Malaysia’s Industry Sponsored Trials, he said the CRM will ensure better communications between potential pharmaceutical industry sponsors and CRO’s with the MOH sites and investigators. There is supportive research infrastructure such as National Medical Research Register, which is an online register in which every clinical trial conducted within the country is recorded. The researcher acknowledged that CRC has been instrumental in establishing patient registries in more than thirty disease areas. Since 1999, Malaysia has mandated that all clinical trial investigators must receive training in relevant research topics such as Good Clinical Practice (GCP) and Good Research Practice (GRP) in order to equip them with the necessary technical expertise and administrative capabilities when conducting the trials.
Another advantage is that the multi-racial and multi-ethnic local patient population providing an excellent opportunity for clinical trial investigators to conduct clinical research on a widely diverse patient population, especially pertaining to their genetic make-up. There is very good transport logistics, and costs are very manageable when conducting clinical trials in the country. Besides, the administrative and other costs incurred during the conduct of these trials in Malaysia will also be kept minimal, Prof Dixon Thomas said.