Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
About
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 inc.
The Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) grant supports researchers and clinical investigators nationwide who want to develop and conduct investigator-initiated clinical trials aligned with the National Heart, Lung, and Blood Institute (NHLBI) research mission. This funding opportunity is designed for researchers testing innovative therapeutic, behavioral, dissemination, implementation science, and prevention strategies through single-site clinical trials. The program encourages trials using cutting-edge designs such as platform trials, adaptive designs, and Bayesian approaches. Eligible researchers should present a strong scientific rationale, comprehensive operational plan, and clear performance milestones. The bi-phasic, milestone-driven award mechanism requires applicants to address project management, participant recruitment and retention, scientific conduct, and results dissemination. While not required, the program strongly encourages the multiple PD/PI model, particularly with team members possessing expertise in biostatistics and clinical trial design. Domestic and international organizations, including foreign entities and non-U.S. components of American organizations, are eligible to apply. Researchers seeking to advance cardiovascular, pulmonary, and blood disease prevention and treatment through rigorous clinical investigation should consider this opportunity.
Funding Facts
● Applications openDeadline
November 2, 2028
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by application cycle
Deadline
2028-11-02
Grant Type
federal
Application Cycle
Annual with specific deadline (November 2, 2028)
Best For
Researchers and clinical investigators conducting single-site clinical trials in cardiovascular, pulmonary, and blood disease research
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no l
Frequently Asked Questions
Who is eligible for Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)?
Domestic and international organizations are eligible to apply. Non-domestic (non-U.S.) entities, non-domestic components of U.S. organizations, and foreign components are allowed. For complete eligibility requirements, refer to Section III of the Notice of Funding Opportunity (NOFO) or visit the official NHLBI funding opportunities website.
How much funding does Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) provide?
Specific funding amounts vary by application cycle. For current funding ranges and details, please consult the official NHLBI Notice of Funding Opportunity or contact the NHLBI directly for the most up-to-date information.
How do I apply for Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)?
Applications should present scientific rationale and a comprehensive scientific and operational plan for your single-site clinical trial. Your application must address project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination plans. Submit through the NIH grants portal (Grants.gov). For detailed submission instructions, deadlines, and application requirements, visit the official NHLBI website and review the complete NOFO.
What can Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) funding be used for?
Funding supports the development and conduct of investigator-initiated single-site clinical trials, including efficacy, comparative effectiveness, pragmatic, and dissemination/implementation science trials. Trials may test therapeutic, behavioral, and prevention strategies relevant to NHLBI's research mission. Innovative trial designs such as platform trials, adaptive trials, and Bayesian designs are encouraged. All supported trials must meet the NIH definition of a clinical trial.
Last updated: July 5, 2026