The Current Status of Clinical Trials in Indonesia

Abstract

Clinical trials in developing countries are under attack by several critics, who claim that the poor quality does not justify publication of results and repetition of trials is considered wasteful. There is truth in these arguments when one considers the bad studies sponsored by either local or multinational companies aimed merely at promotion. In the past, clinical trials in Indonesia were primarily marketing studies, but during the last decade a trend of improvement has been seen where early-phase studies are being performed. International standards are being pursued slowly with the introduction of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Clinical trials for registration approvals are not required in Indonesia, except when the need becomes obvious at premarketing evaluation. While Indonesia must work hard to train investigators, monitors, and clinical coordinators, the government should lay a legal basis for clinical trials. Contract research organizations could be the driving force in establishing clinical trials in Indonesia which meet international quality standards.