Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
National Institutes of Health (NIH)
Funding amount is not limited but must reflect the actual needs of the proposed project.
Maximum project period is five years, with up to one year for the R61 phase and up to four years for the R33 phase.
To support applications for developing and implementing investigator-initiated single-site clinical trials.
Focus on efficacy, comparative effectiveness, pragmatic, and implementation research clinical trials.
Investigators experienced in clinical trials.
Participants in the clinical trials, particularly those from diverse backgrounds.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local governments, state governments, and tribal governments.
Federal agencies and foreign organizations are also eligible.
No specific geographic limitations mentioned, but foreign organizations are eligible to apply.
Projects must be single-site clinical trials that meet the NIH definition of a clinical trial.
Trials should address health disparities and include innovative designs.
Application budgets are not limited but must reflect actual project needs.
No cost-sharing is required.
Application due date is September 11, 2025.
Earliest submission date is January 11, 2025.
Applicants may submit more than one application as long as each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications.
Applications must include a Single-site Justification Plan, Trial Management Plan, Clinical Trials Research Experience, and Community-Engagement Plan.
Applications will be evaluated based on significance, innovation, rigor, feasibility, and expertise.
Applications will undergo a peer review process followed by a second level of review by the Advisory Council.
Scientific and technical merit of the proposed project will be the primary consideration.
Encouragement of community engagement and addressing health disparities.
Applicants must demonstrate a clear plan for project management and risk mitigation.
Alignment with NHLBI's mission and research priorities.
Strong emphasis on innovative trial designs may provide a competitive edge.
Clear project management and milestone tracking.
Failure to adhere to application instructions and guidelines.
Engage with community partners early in the planning process.
Highlight innovative aspects of the trial design in the application.