Drugs

Digital Health Research Grants Available

FDA is seeking applicants for a funding opportunity to explore the role of digital health technologies (DHTs) such as actigraphy, photography, and environmental sensors, in evaluating new drugs. An agency announcement says projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders.

The project objectives are listed as (1) advancing DHTs for clinical drug development, (2) expanding the ability to capture early manifestations of chronic diseases, (3) determining outcomes in populations with unmet medical needs, and (4) enhancing convenience for trial participants by allowing for remote data acquisition in clinical investigations.

The grant scope includes, but is not limited to:

comparing digital measurements to traditional measurements in clinical trials to evaluate drugs;
developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials;
comparing metrics to evaluate continuous measurements; and
capturing early manifestations of chronic diseases through the use of DHTs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome