Key Insights From The FDA's DHT Guidance

By Cindy Howry, VP, eCOA Science

The FDA's latest guidance, issued on December 23, 2023, marks a significant step towards the integration of Digital Health Technologies (DHTs) into clinical trials. This guidance, encapsulated in the "Framework for the Use of DHTs in Clinical Trials," lays down a comprehensive road map for how technologies like wearable devices, implantable and ingestible sensors, environmental monitors, and mobile phone applications can be leveraged to enhance clinical research. The potential of DHTs to streamline data collection, improve participant engagement, and yield more accurate results is immense.

Here's a breakdown of the key areas covered in the FDA's guidance:

• Considerations for DHT Selection
• Design and operation of DHTs
• Use of participant's own DHT and/or technologies
• DHT submissions
• Verification, Validation, and Usability
• Evaluation of endpoints involving DHT data
• Record protection and retention
• Other considerations for sponsors and investigators

Access the full article below for a summary of each section contained above, as well as insights for sponsors and investigators when using these innovative tools.