FDA's Framework for Decentralized Clinical Trials

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

Following the previously published guidance on externally controlled trials, the U.S. Food and Drug Administration (FDA) issued a Framework for the use of Digital Health Technologies (DHT). The DHT document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products. The document outlines the framework the agency will use to

• Implement a multifaceted DHT program;
• Engage stakeholders;
• Establish internal processes to support DHT evaluation;
• Promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development;
• Facilitate the publication of relevant guidance documents.

DHTs can enable the conduct of decentralized clinical trials, where data can be remotely recorded and analyzed directly from participants as part of everyday tasks wherever the participants may be (e.g., at home, school, work, or outdoors). DHTs can also help in collecting data from participants who are unable to report their experiences like infants or cognitively impaired individuals. This type of data collection can improve trial retention rates by enhancing convenience for trial participants and reducing the burden on caregivers. 

For detailed information, please see the Digital Health Technologies for Drug Development webpage. For information on the framework and how to comment, please see the Federal Register Notice.