Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and ReviewRegister
Background and Meeting Objective:
The FDA defines digital health technologies (DHTs) as systems that use computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. Many DHTs are small portable instruments that may be worn or used by trial participants and may allow remote data acquisition in clinical investigations evaluating medical products.
DHTs allow for measurement of a wide range of activities, behaviors, and functioning in real life settings that can be incorporated in trial endpoints during drug development. DHTs may also improve patient access to clinical trials over wide geographic areas, increase patient population diversity, and promote retention by reducing the burden involved in participating in trials by collecting data remotely. In addition, DHTs can facilitate direct collection of information from participants who are unable to report their experiences (e.g., infants, cognitively impaired individuals).
The US Food & Drug Administration, using a cooperative agreement with the Robert J. Margolis, MD, Center for Health Policy at Duke University, is hosting a public workshop to bring together key stakeholders, such as patients, biopharmaceutical companies, DHT companies, clinicians, and academics, to understand the priorities for the development of DHTs for use in clinical trials. This meeting will explore the challenges and opportunities related to the use of DHTs in clinical trials during the drug development process, focusing on actigraphy and other sensor-based measurements. Additionally, this public workshop meets a Prescription Drug User Fee Amendments (PDUFA VII) commitment to convene the first of a series of public workshops by the end of the second quarter (Q2), fiscal year (FY) 2023.
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD006807 totaling $2,575,023 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official view of, nor an endorsement, by FDA/HHS, or the U.S. Government.