Cervical Cancer Phase 2 Study Enrollment Report

This report details a Phase 2 study focused on advanced, recurrent, non-resectable cervical cancer, which was conducted in seven European countries. The study aimed to evaluate an investigative medicinal product (IMP) while addressing the challenges posed by the COVID-19 pandemic. Despite initial delays in regulatory review and site activation due to pandemic-related resource diversion, the study ultimately enrolled 52 patients, exceeding the target of 50. The report outlines the strategies employed by Premier Research to enhance screening and enrollment rates, including optimizing site engagement and maintaining communication with regulatory authorities. It also highlights the impact of a higher-than-expected screen failure rate, attributed to discrepancies in lab results and the health status of the target patient population. The findings emphasize the importance of flexibility and communication in overcoming obstacles during clinical trials, particularly in challenging circumstances. The report concludes with a note on the successful enrollment and the potential for future studies based on this experience.