Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
NIH will fund investigator-initiated multi-site or decentralized clinical trials relevant to its mission, supporting planning and implementation over up to 7 years using a milestone-driven UG3/UH3 grant mechanism.
Funder: National Institutes of Health
Due Dates (Anticipated): February 2027 (Full application deadline, projected)
Funding Amounts: Up to 7 years total: up to 2 years (UG3 phase) + up to 5 years (UH3 phase); specific award amounts not yet published.
Summary: Supports investigator-initiated, multi-site clinical trials—including decentralized and virtual designs—aligned with NIH research priorities.
Key Information: This is a forecasted opportunity; applications are not yet being solicited.
Description
This forecasted NIH opportunity will support the development and implementation of investigator-initiated multi-site clinical trials. Eligible trial designs include efficacy, effectiveness, pragmatic, and/or implementation research, as well as large or complex trials that may be decentralized or virtual. Projects must align with the research missions of participating NIH Institutes and Centers and meet the NIH definition of a clinical trial. The mechanism is bi-phasic: a UG3 start-up phase of up to 2 years, followed by a UH3 implementation phase of up to 5 years, for a total potential duration of 7 years. The objective is to provide both a compelling scientific rationale and a comprehensive operational plan, including project coordination, administration, data management, and biostatistical support. This notice is intended to allow ample time for the formation of collaborations and the development of responsive proposals.
