The National Institutes of Health and the National Heart, Lung, and Blood Institute have issued funding opportunity PAR-25-028, titled Single-Site Investigator-Initiated Clinical Trials. This opportunity supports investigator-initiated single-site clinical trials, including efficacy, comparative effectiveness, pragmatic, and implementation research trials. The trials must align with the research mission of the National Heart, Lung, and Blood Institute and meet the NIH definition of a clinical trial. Innovative study designs, such as platform trials, adaptive, and Bayesian designs, are encouraged. Proposals should aim to address health disparities, enhance community engagement, and increase diverse perspectives in clinical research.

This funding opportunity uses a bi-phasic mechanism (R61/R33), which includes a one-year R61 start-up phase and a four-year R33 clinical trial execution phase. Successful completion of specific milestones in the R61 phase is required to transition to the R33 phase. Milestones may include finalizing study protocols, securing regulatory approvals, and demonstrating participant enrollment. The proposed clinical trial must be single-site, meaning all participant interventions and data collection occur under the direction of one investigational team at a single location, though participants may come from multiple clinics or areas.

The purpose of the R61 phase is to finalize operational details, such as protocols, manuals, and regulatory requirements. Investigators must demonstrate readiness to conduct the trial efficiently during the R33 phase, including plans for participant recruitment, retention, and milestone tracking. The National Heart, Lung, and Blood Institute will conduct administrative reviews throughout the study to ensure progress toward achieving milestones. Trials supported under this opportunity are expected to contribute to the evidence base for improving health outcomes, clinical practice, or community interventions.

Eligible applicants include higher education institutions, non-profit organizations, for-profit entities, local governments, and federally recognized tribal governments. Foreign organizations and components of United States organizations are also eligible. The NIH encourages applications from individuals from underrepresented groups in science and emphasizes the inclusion of diverse perspectives in the research process.

Applications must include several required components, including a plan for enhancing diverse perspectives, a community engagement plan, and a trial management plan. The plan for enhancing diverse perspectives outlines actionable strategies to promote inclusivity and broaden perspectives in the research. Applicants must also demonstrate their prior clinical trial research experience and describe how project management and risk mitigation strategies will ensure successful trial completion. Core milestones for both phases must be clearly defined and include enrollment goals for diverse populations, data collection, and dissemination of results.

There are multiple submission deadlines, including February 11, 2025, and June 11, 2025, with subsequent cycles available. Letters of intent are due thirty days before the application deadline. Applications must be submitted via Grants.gov and follow NIH application instructions. Funding decisions will be based on scientific merit, the ability to meet milestones, and alignment with program priorities. For further information, applicants are encouraged to contact National Heart, Lung, and Blood Institute program staff prior to submission.