10/11 April 2024
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
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.