DHTs in Clinical Trials: Key Points From the FDA's Draft Guidance

Signant's Bill Byrom offers expert analysis of the FDA's draft guidance on Digital Health Technologies (DHTs) in clinical trials. Explore critical regulatory considerations that will shape how sponsors implement wearables, sensors, and mobile devices in clinical research.

The paper also clarifies key validation requirements, BYOD considerations, and data integrity safeguards needed for regulatory submission. Particularly valuable are the practical recommendations on managing software updates, minimizing missing data, and demonstrating measurement accuracy.

Whether you're exploring decentralized trial models or selecting appropriate technologies for specific patient populations, this guide aligns FDA expectations with established industry consensus from DiMe, DIA, and C-Path ePRO Consortium.

Download our whitepaper to ensure your DHT implementation meets FDA expectations for your next clinical trial.