5PSQ-142 Multisite clinical trials: what about the experimental drug circuit? Failure mode, effects and criticality analysis

<h3>Background and Importance</h3> Multisite coordination of clinical trials could be a key lever to promote patient recruitment, facilitate access to innovation, and enhance the attractiveness of sites. This approach requires coordination at both the clinical research and the pharmaceutical levels. The involvement of multiple pharmacies in the distribution process of the experimental product differs from its usual management and introduces new risks. <h3>Aim and Objectives</h3> The TRINITI project aims to identify, assess, and mitigate the new risks associated with this pharmaceutical activity to secure the circuit of the experimental product. <h3>Material and Methods</h3> A multidisciplinary working group was established, comprising members from the pharmaceutical coordination unit (one TRINITI project manager, two pharmacists), a representative from the clinical research unit, and a pharmacist from a satellite pharmacy centre. Subsequently, a preliminary risk analysis was conducted using the Failure Mode, Effects and Criticality Analysis method (FMECA) before the beginning of the first multisite clinical trial. <h3>Results</h3> In total, 56 new subprocesses were identified, associated with 114 risks. Among these risks, 82% (n=93) were linked to the operational aspect of the activity. The majority of identified risks were considered acceptable (78%, n=89). Of the 24 risks with tolerable criticality, 30% are related to the preparation of clinical trials in satellite centre pharmacies. The risks of insufficient funding and the unavailability of vehicles were deemed unacceptable. Twelve risks were rated with a potential severity of 5, primarily associated with the feasibility of the coordination activity and the validation of additional projected costs. For all identified risks, 29 preventive barriers have been implemented. <h3>Conclusion and Relevance</h3> This risk analysis has pinpointed the most critical steps in the pharmaceutical circuit and facilitated the implementation of preventive measures to mitigate their criticality. It is now crucial to assess the residual criticality following these measures. In this way, this analysis enables the secure deployment of the pharmaceutical aspect of the coordination project. In continuation of this work, a post-analysis of risks should be conducted based on the initial experiences. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest