The FDA issued the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development. The Digital Health Technology (DHT) framework document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
The document outlines the framework FDA will use to implement a multifaceted DHT program for drugs and biological products. The DHT program will engage stakeholders and include workshops and demonstration projects; establish internal processes to support DHT evaluation for use in drug development; promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development; and 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 such as 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 expand access to underrepresented and diverse patient populations and improve trial retention rates by enhancing convenience for trial participants and reducing the burden on caregivers.
For information on the DHT program, please visit the Digital Health Technologies for Drug Development webpage. For information on the framework and how to comment, please see the Federal Register Notice.
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