Overcoming Enrollment Challenges in a Phase 2 Prostate Cancer Clinical Trial

This document is a case study detailing the challenges faced in a Phase 2 clinical trial for metastatic castration-resistant prostate cancer (mCRPC). The study aimed to increase enrollment for a therapy developed by a U.S.-based company. It outlines specific enrollment challenges, including the introduction of a competing therapy without consulting key stakeholders, restrictive eligibility criteria, and adverse effects from concomitant medications leading to higher patient drop-out rates. The case study presents strategies recommended by Premier Research to address these issues, such as expanding the study to Europe, creating a feasibility questionnaire with input from key opinion leaders, and enhancing engagement with study personnel. The outcomes indicate that these strategies successfully put the trial back on track to meet its enrollment milestones through increased site engagement and tailored protocol amendments. The document emphasizes the importance of stakeholder engagement in the protocol design stage and the need for site-specific planning prior to the trial launch.