FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations Unlocking the Full Potential of Digital Health Technologies to Support Medical Product Development and Innovation

https://www.fda.gov/news-events/fda-voices/fda-weighs-development-and-use-digitally-derived-measures-clinical-investigations?utm_medium=email&utm_source=govdelivery FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations For decades, much of what we have known about a participant’s health during a clinical investigation has been shaped by what could be observed, measured, or reported during periodic visits to a research site or clinic. Among the most promising opportunities in healthcare today is the use of digital health technologies (DHTs) that are expanding that window. DHTs, especially those enabled by artificial intelligence, can capture information about a person’s health continuously, in real time, and in the context of a person’s everyday life. These technologies can bring clinical investigation closer to participants and patients in their daily lives and at various stages along their health journey. DHTs also enable earlier detection of treatment effects or safety signals and may facilitate decentralized clinical trials. The opportunities associated with DHTs align directly with the U.S. Food and Drug Administration’s mission to protect, promote, and advance public health, and they build on the agency’s longstanding commitment to supporting responsible innovation in the development and regulation of medical products. With this goal in mind, the FDA’s medical product centers have jointly published a white paper entitled: “Key Considerations for the Development and Use of Digitally Derived Measures for Clinical Investigations.” The white paper highlights key considerations drawn from existing FDA guidances for the development and use of digitally derived measures (DDMs) as outcomes in clinical investigations. This work directly advances one of the FDA’s express priorities under Public Health Pillar 1, Innovation and Global Leadership: strengthening the use of emerging technologies, including digital health technologies.