Present clinical trial regulatory system and strategies for improvement in Thailand

Abstract

The study aimed to identify gaps and to develop strategies for improving the clinical trial regulatory system in Thailand. Two-step cross-sectional survey was conducted. The first questionnaire addressed the current situation and the expected system sent by mail. The participants were from the lists of ethics committee members available on-line and others obtained from Food and Drug Administration (FDA). The second questionnaire determined the strategies and methods to improve the regulatory system. The participants were the attendees at the ThaiTECT meeting. The first questionnaire with response rate of 26.9 percent showed that the current situation was appropriate. However, to provide a better system, FDA and the ethics committees should improve on several aspects. The second questionnaire with response rate of 32.5 percent showed that the current priority for the ethics committee was the standard and accreditation, and that required for the FDA was the implementation of the quality system, especially the approval criteria. In addition, the capacity building was also important for all stakeholders. The study concluded that to improve the clinical trial regulatory system, the ethics committee and FDA should implement the quality and accreditation systems toward the international standard, and capacity building should aim at GCP training.

:TJPS-2019-0169.R3