Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
NHLBI plans to fund single-site clinical trials (R61/R33) testing therapeutic, behavioral, or prevention strategies, encouraging innovative designs.
Funder: National Institutes of Health
Due Dates: November 2, 2028
Funding Amounts: No published ceiling or floor; actual award size and duration will depend on project scope and NIH/NHLBI budget policies.
Summary: Supports investigator-initiated, single-site clinical trials relevant to the NHLBI mission, including efficacy, comparative effectiveness, pragmatic, and implementation science trials.
Key Information: Foreign subawards/subcontracts are not allowed under this NOFO.
Description
This Notice of Funding Opportunity (NOFO) invites applications to develop and conduct investigator-initiated, single-site clinical trials that align with the mission of the National Heart, Lung, and Blood Institute (NHLBI). Supported trials may include efficacy, comparative effectiveness, pragmatic, and/or dissemination and implementation science studies. Innovative trial designs such as platform, adaptive, and Bayesian approaches are encouraged. Projects must meet the NIH definition of a clinical trial and should address project management, participant recruitment and retention, milestones, scientific conduct, and dissemination plans.
Applications should propose strategies to increase community engagement from intervention design through implementation and sustainability, with an emphasis on closing health outcome gaps in the US population. The use of a multiple Principal Investigator (PD/PI) model is encouraged, particularly including expertise in biostatistics and clinical trial design.
