Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

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 implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. • The clinical trials must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial. • 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.