Use of failure mode and effects analysis for risk analysis of investigational drug products management in clinical trials

Background The purpose of this study is to prospectively analyze the entire process of managing investigational drug products (IP) in the investigational drug service (IDS) pharmacy, explore the safety risks and corrective actions in the management of IP, and ensure the safety of participants and the quality of clinical trials. Methods Failure mode and effects analysis (FMEA) was conducted at a tertiary general hospital. By analyzing the risk priority number (RPN) of each failure mode, failure modes with significant impacts on participant safety, data integrity, and regulatory compliance in clinical trials were identified, and implementation priorities were determined. Corresponding corrective actions were then formulated. Results A total of 44 failure modes were identified, with 31 classified as high-risk. The causes of these failure modes were primarily related to factors such as IDS pharmacists failing to strictly review documents, noncompliance with standard operating procedures, and investigators’ lack of familiarity with clinical trial protocols. Finally, 5 general and 10 specific corrective actions for particular steps were proposed. Among the top 10 RPN scores, 60.0% were related to the drug dispensing process, and 62.5% of the highest severity scores (5 points) were also associated with this step. The most critical general actions formulated by the team included creating detailed flowcharts for each operational step, developing pocket guides, and enhancing training for pharmacists and investigators. Conclusion Through the active participation of IDS pharmacy staff, FMEA successfully identified and prioritized potential failure modes in the IDS pharmacy management process. Corrective actions were proposed to ensure participant safety and continuously improve the quality of clinical trials and IP management.