NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
Funding available for high-risk clinical trials and related mechanistic studies; one clinical trial per application. Learn more at niaid.nih.gov/research/role.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: May 13, 2025 | September 15, 2025 | January 13, 2026 | May 13, 2026 | September 14, 2026 | January 13, 2027
Funding Amounts: No budget cap; project period up to 5 years; budgets must reflect actual needs of the proposed high-risk clinical trial.
Summary: Supports investigator-initiated, high-risk clinical trials and mechanistic studies in NIAID priority areas; one clinical trial per application.
Key Information: All planning must be complete at submission; prior consultation with NIAID is required for budgets ≥$500,000 direct costs/year.
Description
This opportunity supports the implementation of investigator-initiated, milestone-driven, high-risk clinical trials and associated mechanistic studies in areas aligned with the mission and high-priority research areas of the National Institute of Allergy and Infectious Diseases (NIAID). Mechanistic studies are encouraged, as they can advance understanding of human diseases and inform future therapeutic strategies. Only one clinical trial may be proposed per application.
The program is intended for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks or infrastructure. The focus is on high-risk trials, defined as those involving non-routine interventions, unlicensed products, or licensed products used for unapproved indications, or those requiring regulatory oversight (e.g., IND/IDE).
Applicants must be ready to implement the proposed trial at the time of award; all planning activities must be completed prior to submission.
