Prospective Risk Management in the Process of Clinical Studies in the Republic of Serbia Nikola Rabrenović1 , Ivana Stević1 and Valentina Marinković1

Background: In Serbia, as well as worldwide, clinical trials are a significant and unavoidable part of the development of new medicines. There is limited research on prospective risk management in clinical trials in Serbia, underscoring the need for systematic approaches, such as the failure mode and effects analysis (FMEA) method. The effectiveness of this complex process largely depends on knowledge and experience in the field of management. Like any other process, clinical trials are subject to various risks for both the company and the patient. Objectives: The purpose of this article is to conduct a prospective, qualitative study on the risk management of clinical trials in the Republic of Serbia, to identify, assess, and reduce risks for both patients and companies, and to offer corrective measures for reducing their frequency and consequences. Materials and Methods: A focus group applied the FMEA method to identify, assess, and mitigate risks. Each risk was assessed based on severity, probability, and detectability, and then a risk priority number (RPN) value was calculated. For the most significant risks, corrective measures were proposed, and the RPN was recalculated. The research was conducted from December 12, 2022 to March 8, 2023. Results: In total, 20 risks were identified with RPN values ranging from 10 to 192, of which five had RPN > 100. The minimum RPN value among the five most significant risks was 105, and the maximum was 192. After the proposed corrective measures, there was a significant reduction in the RPN values across all five risks, ranging from 57.14% to 83.33% when compared to the initial values. Conclusion: The FMEA method has proven to be a useful instrument not only for identifying and predicting potential risks, but also for their control.