FDA's Vision On PRO Collection For RWE

In this presentation, a distinguished panel of experts illuminates the crucial role of patient-reported outcomes (PROs) in shaping regulatory decisions and drug development strategies, particularly in light of FDA expectations. This session is designed for clinical researchers, trial managers, real-world evidence teams, and patient engagement specialists seeking to align their data strategies with FDA guidelines. Ari Gnanasakthy, Willie Muehlhausen, and Derk Arts provide valuable insight by dissecting recent FDA guidance on PRO data collection methods, timing, and quality. The discussion emphasizes the importance of prioritizing participant experience while ensuring data integrity, as well as key FDA insights regarding PRO data quality and best practices to minimize errors and enhance reliability. The speakers address common challenges such as ePRO fatigue and highlight the increasing significance of tolerability data in differentiating therapeutic options. Watch the full webinar to uncover best practices and innovative approaches that can transform your understanding of PRO data collection and its implications for regulatory success.