Driven by the pandemic, one of the most rapid evolutions in clinical trails in the past few years has been the shift to decentralized trails and supporting them the implementation of digital technologies. To address the shifting paradigm, the FDA and Duke University are hosting a Public Workshop on the 'Development of Digital Health Technologies'. I've attended several other workshops by this collaboration and they have always been thought provoking and good opportunities to ask questions and hear questions and answers from others in the field.
From the announcement:
Summary REGISTRATION
FDA and the Duke-Robert J. Margolis, MD Center for Health Policy will host the virtual public workshop “Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review” on March 28, 2023, 1:00 PM – 4:15 PM ET and March 29, 2023, 1:00 PM – 4:45 PM ET. The purpose of the public workshop is to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcomes measures using DHTs.
FDA plans to discuss priorities and challenges for the development of DHTs to support clinical drug trials including:
- improving participant access, increasing diversity, and facilitating engagement through remote trial-related measurements;
- understanding patient and industry perspectives;
- understanding opportunities for remote data acquisition directly from trial participants; and
- using DHTs to capture clinical outcomes measures.
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