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: July 20, 2026 (Open date) | August 20, 2026 (Full application due)
Funding Amounts: Up to $1,100,000/year for up to 2 years; up to 2 awards expected
Summary: Supports research on digital health technologies for remote data acquisition in clinical drug and biological product development.
Description
This opportunity from the U.S. Food and Drug Administration (FDA) invites applications for research projects focused on the use of digital health technologies (DHTs), such as sensors, software, and connected devices, to enable remote data acquisition in clinical investigations that support drug and biological product development. Projects may include, but are not limited to, comparing digital and traditional clinical measurements, developing novel endpoints using DHTs, evaluating continuous monitoring metrics, and capturing early signs of chronic diseases. The program aims to advance the adoption and regulatory understanding of DHTs in clinical drug development, improve outcomes for populations with unmet medical needs, and enhance trial participant convenience.
