Advancing the use of Digital Health Technologies in drug development

Digital Health Technologies (DHTs) including smartphones and wearable sensors are rapidly reshaping how patient data are collected, analyzed, and applied in clinical research. DHTs generate massive, high-frequency streams of physiological, behavioral, and environmental data that hold enormous potential for creating more sensitive trial endpoints, enabling decentralized assessments, and supporting precision drug development. At the same time, significant challenges remain in methodology, infrastructure, and regulatory adoption. This session will explore advances in digital health technologies and their translation into drug development and regulatory science. Speakers will present novel statistical approaches for extracting sensitive and interpretable endpoints from complex wearable and smartphone data; discuss the leadership, standards, and infrastructure needed to revitalize digital endpoint development across multiple modalities; and provide a regulatory perspective on current FDA guidance and evolving frameworks for endpoints derived from digital health technologies.