Drug approval rates in biotech are dismal, with CNS proving to be a particularly challenging area for development. Trials resulting in countless failures have used outdated models, failing both primary endpoints and to advance innovation in any sense. In 2023, we conduct trials more quickly and efficiently, but how are we measuring success? Is there an opportunity to incorporate real world data in trial design and execution, to maximize impact regardless of clinical outcomes? How can we build knowledge iteratively, using earlier stage trials to de-risk drug development and reduce late stage failures? A leading policy expert, industry executive, researcher, and psychiatrist will discuss the promises and pitfalls of innovative clinical trial approaches in CNS – including stratifying patients, machine learning and AI practices, decentralized studies, leveraging multiple sources of data and clinic feedback, as well as sharing results to transform the space.