Retention and Compliance in a Clinical Trial Case Study

This case study presents an analysis of retention and compliance in a multicenter, open-label clinical trial utilizing the Linkt mobile application for electronic patient-reported outcomes (ePROs). The study involved 36 participants and aimed to address challenges in patient retention and compliance, which are critical for the scientific validity of clinical trials. The findings indicate that 88% of participants were retained throughout the study, with a high compliance rate of 89% across all participants. Notably, compliance among retained participants reached 95%. The study also highlights the impact of site-specific behaviors on retention and compliance, revealing significant differences in outcomes based on site performance. Statistical analyses demonstrated that sites with issues in administering ePROs had lower retention and compliance rates. The results underscore the importance of proper training for site staff to enhance participant engagement and adherence to study protocols. Overall, the use of the Linkt app contributed to high retention and compliance rates, suggesting its potential effectiveness in clinical trial management.