The Current Status of Clinical Trials in Malaysia

Abstract

Although Malaysia has a relatively long history of clinical research, its participation in international drug research is very recent. With the increasing widespread implementation of Good Clinical Practice (GCP) worldwide, there is mounting pressure for Malaysia to adopt GCP as part of its regulation of clinical trials. There will, however, be challenges in implementing GCP guidelines in Malaysia. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspection are among some of the more difficult issues. Nevertheless, the obvious benefit of GCP is acknowledged not only by Malaysia's Drug Control Agency but also by the research community of Malaysia. With the increasing active participation of Malaysia in international drug research, the implementation of GCP warrants urgent attention.