White Paper
What Does the New FDA DHT Guidance Mean?
A Practical Guide for Sponsors
Overview
In December 2023, the FDA released its final guidance on the use of digital health technologies (DHTs) for remote data acquisition in clinical investigations. This marked an important milestone, signifying willingness from regulators to adopt new digital clinical measurements.
In this Ametris white paper, we've synthesized the FDA's guidance into a practical, actionable resource to help sponsors, particularly those new to DHTs, maximize their value in clinical investigations.
What You'll Learn
- What the regulators expect in a submission
- What to look for in selecting the right DHT
- Steps needed to ensure the DHT is fit for purpose
- How to operationalize DHTs in clinical trials
- Considerations to evaluate clinical endpoints from DHT data