Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Funding for single-site clinical trials on different treatment strategies aligned with NHLBI's research mission using a milestone-driven mechanism.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: January 11, 2025 (Open date) | February 11, 2025 (New) | March 11, 2025 (Renewal/Resubmission/Revision) | May 11, 2025 (AIDS) | June 11, 2025 (New) | July 11, 2025 (Renewal/Resubmission/Revision) | September 11, 2025 (AIDS) | October 10, 2025 (New) | November 10, 2025 (Renewal/Resubmission/Revision) | January 11, 2026 (Current closing) | January 12, 2026 (Final/Expiration)
Funding Amounts: Budgets are not limited; project period up to 5 years (1 year R61, up to 4 years R33); actual funding based on project needs and NIH appropriations.
Summary: Supports investigator-initiated, single-site clinical trials relevant to NHLBI’s mission using a bi-phasic, milestone-driven R61/R33 mechanism.
Key Information: Only single-site trials (not multi-site); direct costs ≥$500K/year require NHLBI staff consultation before applying.
Description
This funding opportunity supports the development and implementation of investigator-initiated, single-site clinical trials relevant to the mission of the National Heart, Lung, and Blood Institute (NHLBI). Eligible trials may include efficacy, comparative effectiveness, pragmatic, and/or implementation research clinical trials testing therapeutic, behavioral, or prevention strategies. The mechanism is bi-phasic: the R61 phase supports start-up activities (e.g., protocol finalization, IRB approval, DSMB setup), and the R33 phase supports trial execution, including participant enrollment and follow-up. Only single-site trials (one investigational site overseeing all enrollment and interventions) are eligible. Multi-site, Phase I, basic/mechanistic, or safety-only trials are not eligible.
Applicants must present a comprehensive scientific and operational plan, including project management, recruitment and retention strategies, performance milestones, and plans for dissemination. Community engagement and efforts to address health disparities are strongly encouraged. Applications must propose clear, measurable milestones for both phases and include required attachments (single-site justification, trial management plan, clinical trials research experience, and community engagement plan).
