Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
This grant supports research on using digital health technologies for remote data collection in clinical trials to advance drug and biological product development.
Funder: Food and Drug Administration
Due Dates: August 20, 2026 (Full application deadline)
Funding Amounts: Up to $1,100,000 per award per year; maximum project period 2 years; up to 2 awards expected.
Summary: Supports research on digital health technologies for remote data acquisition in clinical investigations to advance drug and biological product development.
Description
This funding opportunity supports projects that investigate the use of digital health technologies (DHTs)—such as actigraphy, photography, and contactless sensors—for remote data acquisition in clinical investigations to support drug and biological product development. The goal is to advance the integration of DHTs in clinical drug development by enabling new endpoints, improving measurement of disease manifestations, and enhancing participant convenience through remote monitoring. Projects may compare digital and traditional measurements, develop novel endpoints, or use DHTs to capture early signs of chronic diseases. Both clinical trial and non-clinical trial proposals are accepted.
