System analysis and design for clinical trail control in Thailand

Abstract

The purposes of this research were to analyze the current situation of the clinical trial system in Thailand, to design the practical clinical trial control system in Thailand, to identify the gap between current situation and expected clinical trial control system and to develop strategies for the clinical trial control system. This study consisted of four phases. The first phase was a literature review. Second phase used survey questionnaires asking current situation and opinion on the expected system mailed to 1,260 stakeholders including drug producers or importers, investigators, ethical committee’s members and Food and Drug Administration personnel. The overall response rate was 26.9 percent. The results showed that even all parties considered that the current situation functioned moderately well, the proposed key issues in the designed model would create a better system. The third phase provided gap analysis and information from the in-depth interview with key informants from the parties to use in developing strategies to bring the current system upward to the designed model. Lastly, questionnaires were distributed to parties at their annual meeting to verify the proposed strategies with the response rate of 32.5 percent. The study showed that all parties are totally agree that the objectives of the clinical control system should focus on the standard and oversight of ethical committee, the effective control of investigational drug by Food and Drug Administration and capacity building in all related agencies. The current priority was the standard and accreditation of ethical committee, which needed political commitment to issue human research act. As the acts is still in-process, Food and Drug Administration should take initiation in establishing the recognition criteria for ethical committee in reviewing clinical trial of investigational drugs. Another priority was to improve efficiency of Food and Drug Administration’s work. Even many regulations had been established, there were evidences showing lack of understanding and compliance. Therefore, Food and Drug Administration should promote understanding of role, regulation, procedure, and timeline to the public and concern parties. Lastly, capacity building was essential for conducting research and development especially for drugs originated in Thailand. It could start with capacity building for conducting clinical trial originated from foreign countries. Methods for development were proposed and agreed by concerned parties. The result from this research could be the inputs for policy development and procedural improvement to strengthen the clinical trial control system in Thailand to be at the international standard and acceptance.