An exploratory application of failure mode and effects analysis to recruitment and retention challenges in a clinical trial

Clinical trials are a critical phase in the development of new drugs, and the recruitment of research participants is a pivotal prerequisite for the success of these trials. However, participants recruitment and retention often face numerous challenges, such as delayed recruitment progress, high rates of informed consent failure, and poor participants compliance, which significantly impact the timeline and quality of clinical trial projects. Through in-depth analysis of 4 core processes of participants recruitment and retention, this study explores the application of the Failure Mode and Effects Analysis (FMEA) method to identify four high-risk failure modes and three medium-high risk failure modes within the core processes of participants recruitment and retention. By implementing a multifaceted and systematically proactive approach, including leveraging established relationships with community providers, appointing dedicated full-time personnel, providing targeted incentives for both research staff and participants, and maintaining persistent communication, this exploratory study integrates preemptive risk identification and mitigation strategies aimed at participant recruitment and retention. This methodology seeks to establish a sustainable model for continuous improvement in clinical trial efficiency and participant engagement, focusing on the early detection and resolution of potential barriers.