This Notice of Funding Opportunity (NOFO) supports applications to develop and implement 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. These trials may include ones that test different therapeutic, behavioral, 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, subject 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 increasing community engagement and reducing health inequties and disparities.
This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).
Deadlines:
- Letter of Intent Due Date(s): 30 days prior to the application due date
- New Applications: Feb 11, 2025; June 11, 2025
- Renewal / Resubmission / Revision Applications: March 11, 2025; July 11, 2025
- AIDS Applications: May 11, 2025; Sep 11, 2025
PAR-25-028 Expiration Date September 12, 2025
ESI applicants can be the PI/PD of an application providing they can show support of investigators with appropriate clinical trials experience . ESIs are encouraged to be part of the study team and they should be budgeted for support at a level appropriate for the role on the project.