Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Can you apply?
This grant is for research organizations conducting single-site, investigator-initiated clinical trials supported by the National Heart, Lung, and Blood Institute (NHLBI). Eligible applicants include U.S. institutions, researchers, and foreign organizations (though foreign subawards/subcontracts are prohibited as of May 2025). Trials must test therapeutic, behavioral, dissemination, implementation, or prevention strategies relevant to NHLBI's mission. The trial must meet NIH's definition of a clinical trial and may use innovative designs like platform trials, adaptive designs, or Bayesian approaches.
Applications should present strong scientific rationale, comprehensive trial plans, project management strategies, recruitment/retention approaches, and dissemination plans. The multiple PD/PI model is strongly encouraged. Applicants should include expertise in biostatistics and clinical trial design.
This grant is for research organizations conducting single-site, investigator-initiated clinical trials supported by the National Heart, Lung, and Blood Institute (NHLBI). Eligible applicants include U.S. institutions, researchers, and foreign organizations (though foreign subawards/subcontracts are prohibited as of May 2025). Trials must test therapeutic, behavioral, dissemination, implementation, or prevention strategies relevant to NHLBI's mission. The trial must meet NIH's definition of a clinical trial and may use innovative designs like platform trials, adaptive designs, or Bayesian approaches.
Applications should present strong scientific rationale, comprehensive trial plans, project management strategies, recruitment/retention approaches, and dissemination plans. The multiple PD/PI model is strongly encouraged. Applicants should include expertise in biostatistics and clinical trial design.
Program description
This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research organizations conducting single-site, investigator-initiated clinical trials supported by the National Heart, Lung, and Blood Institute (NHLBI). Eligible applicants include U.S. institutions, researchers, and foreign organizations (though foreign subawards/subcontracts are prohibited as of May 2025). Trials must test therapeutic, behavioral, dissemination, implementation, or prevention strategies relevant to NHLBI's mission. The trial must meet NIH's definition of a clinical trial and may use innovative designs like platform trials, adaptive designs, or Bayesian approaches.
Applications should present strong scientific rationale, comprehensive trial plans, project management strategies, recruitment/retention approaches, and dissemination plans. The multiple PD/PI model is strongly encouraged. Applicants should include expertise in biostatistics and clinical trial design.
How to apply
Application links
Required documents
- SF-424 (R&R) application form
- Project Narrative (with scientific rationale and trial plan)
- Budget and Budget Justification
- Biosketch(es) for PD/PI and key personnel
- NHLBI-specific forms or supplements
- Letters of support (institutional, participant recruitment sites)
Program contact
- 👤 National Institutes of Health
- 📧 NHLBIDCVSClinical@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.840 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$9,471,643
-
$8,728,007
-
$7,692,108
-
$4,748,073
-
$4,329,292
-
$3,974,800
-
$3,948,062
-
$3,945,932
-
$3,945,135
-
$3,868,722
Top States by Funding
- MA 7 awards $24.6M
- NY 5 awards $17.8M
- WA 5 awards $16.2M
- CA 8 awards $14.1M
- PA 6 awards $14.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.840). How funding has trended year over year.
| 2024 | $68,908,737 | |
| 2025 | $72,174,672 |
FAQ
Who can apply for this grant?
U.S. institutions, researchers, and foreign organizations can apply. However, foreign subawards/subcontracts are prohibited as of May 2025. Unfunded collaborations and foreign consultants are allowed.
What types of clinical trials are supported?
The grant supports efficacy, comparative effectiveness, pragmatic, and dissemination/implementation trials. Innovative designs like platform trials, adaptive trials, and Bayesian designs are encouraged.
What must applications include?
Applications require scientific rationale, comprehensive trial plan, project management, recruitment/retention strategy, performance milestones, and dissemination plan. Community engagement approaches are essential.
Is this a single-phase or multi-phase award?
This uses a bi-phasic, milestone-driven mechanism with R61/R33 phases. The R61 phase focuses on developing the trial; R33 funds the actual trial conduct.
Does the trial need to be relevant to NHLBI's mission?
Yes. Your trial must align with the National Heart, Lung, and Blood Institute's research priorities. Review the NHLBI website before applying.
💡 Tips for applicants
- Assemble a strong team early, including a PD/PI with biostatistics and clinical trial design expertise. Multiple PD/PIs are strongly encouraged.
- Detail your recruitment and retention strategy specifically. Reviewers focus heavily on feasibility and participant engagement plans.
- Clearly demonstrate how your trial addresses gaps in health outcomes within the U.S. population and increases health equity.
- Use innovative trial designs if applicable (platform, adaptive, Bayesian). Standard designs must have strong justification.
- Plan for community engagement from intervention design through implementation and sustainability, not just at the end.
⚠️ Common mistakes
Applicants fail to demonstrate feasibility of recruitment/retention timelines for the proposed participant population. Weak or missing alignment with NHLBI's research mission and strategic priorities. Insufficient detail on how the trial design and implementation will address health disparities and engage communities.
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