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Understanding Priorities for the Use of Digital Health Technologies Day 1

Duke Margolis
1.95K subscribers
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1.4K views 2 years ago
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 Admi …...more
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Understanding Priorities for the Use of Digital Health Technologies Day 1
16Likes
1,401Views
2023Mar 30
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, hosted 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 explored 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. 0:00 Welcome 5:29 Opening Remarks from FDA 9:32 Session 1: Perspectives on Use of DHTs in Clinical Trials 1:53:35 Session 2: Impact of DHTs on Clinical Trial Accessibility and Diversity 2:59:55 Closing Remarks

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Duke Margolis

1.95K subscribers