Clinical Research - A Potential Market in Malaysia

Clinical trials have been very crucial when it comes to research and development of new drugs and treatments. With Asia booming as the power house in pharmaceutical sector, it is of no surprise that Malaysian government is joining other Asian countries in tapping into this sector.

Malaysia is one of the countries in Asia which has everything to offer when it comes to pharmaceutical research and development, be it the clinical trials or the facilities. Yet, Malaysia seems to be bypassed by foreign investors due to the lack of publicity as well as some problems that happen in Malaysia, such as delayed timelines, bureaucracy, and long approval processes.

In order to succeed in this industry, BeST programme has incorporated clinical research into the technical module. The first two sessions were on IP and ethics. Moving on to the third day, the session got much more challenging and informative.

We studied the role of sponsors for clinical trials. The sponsors have to select for capable candidates as investigators. Application for licenses, quality control and quality assurance are also sponsor’s responsibilities to ensure that clinical protocols and designs are carried out with accordance to the standard procedures and to ensure that the produced results are reliable.

Next, we also were taught on good clinical practice (GCP). This is a crucial part under clinical trials because trials involve human patients. GCP plays a very crucial role in protecting the human subjects from being exploited. This is when informed consent comes into the picture, where each human participant has the right to decide whether or not to participate. Since informed consent is not a contract, participants have the right to withdraw from the trial at any time.

The session ended with the importance of safety reporting, which more specifically known as adverse event reporting. This reporting system is very important because it takes into account the ethical and legal responsibilities in obtaining and analyzing safety details. Furthermore, it permits effective communication of correct information to regulators, physicians as well as the consumers.

From the session, it was understood that healthcare and clinical research have great potential in Malaysia. It is enlightening that the government has taken extra measures to strengthen the human resource force by incorporating this session into BeST programme. It is time for the government to take prompt action to build up experience healthcare professionals. If no concrete steps are taken, we will lose out. It is time for us to sit tight, be bold and move forward.