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The Thai Journal of Pharmaceutical Sciences

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 present situation and the expected system sent by mail. The participants were from the lists of ethics committee (EC) members available online 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 Thailand Toward Excellence in Clinical Trials meeting. The first questionnaire with response rate of 26.9% showed that the present situation was appropriate. However, to provide a better system, FDA and the EC should improve on several aspects. The second questionnaire with response rate of 32.5% showed that the present priority for the EC 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 EC and FDA should implement the quality and accreditation systems toward the international standard, and capacity building should aim at good clinical practice training.

Publisher

Faculty of Pharmaceutical Sciences, Chulalongkorn University

First Page

277

Last Page

283

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