Atrial Fibrillation Phase 3 Study Case Study

This case study details the challenges and solutions encountered during a Phase 3 atrial fibrillation (AFib) study, focusing on direct-to-patient enrollment. The study faced significant recruitment difficulties due to strict eligibility criteria and a target demographic primarily consisting of older adults, many of whom lived far from traditional study sites. Initial enrollment was slow, with notable drop-offs during the medical record collection and review phases, which contributed to delays in consent and screening. To address these issues, Science 37 implemented a Direct-to-Patient Site, enabling participants to engage from home. The study team collaborated with the sponsor to enhance recruitment strategies, including simplifying eligibility checks and expediting medical record reviews. These adjustments led to a significant increase in enrollment rates. The case study also highlights key lessons learned, such as the importance of maintaining continuity among investigators and aligning prescreening questionnaires with established criteria to improve patient qualification.