Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) FOR-HL-25-028

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), intends to release a Notice of Funding Opportunity (NOFO) under the number FOR-HL-25-028. This grant initiative focuses on supporting investigator-initiated, single-site clinical trials that require a clinical trial component. It will utilize the R61/R33 funding mechanism and is designed to encourage the implementation of trials that span from early efficacy assessments to advanced stages of clinical research. These trials must be aligned with the NHLBI mission areas, which include heart, lung, and blood diseases as well as sleep disorders, and must meet the NIH definition of a clinical trial. The program aims to solicit a wide variety of clinical trial proposals, encompassing efficacy studies, comparative effectiveness research, pragmatic designs, and implementation trials. Emphasis is placed on innovative methodologies, including but not limited to adaptive trials, Bayesian designs, and platform trials. The NOFO is forecasted, which indicates that applications are not yet being accepted; however, the notice has been issued in advance to allow investigators ample time to prepare robust and collaborative project proposals. Funding will be awarded through a grant mechanism, and while details on the total available funding and individual award amounts have not yet been disclosed, this opportunity is supported under several Assistance Listings. These include listings for cardiovascular, lung, blood disease research, sleep disorders, and translational and implementation science. Notably, no cost-sharing or matching is required for this opportunity, removing a common barrier to entry for smaller organizations or new applicants. Eligible applicants span a wide range of entities, including nonprofit organizations with 501(c)(3) status, public and private institutions of higher education, small businesses, county governments, public housing authorities, tribal organizations (both federally recognized and not), independent school districts, and for-profit organizations other than small businesses. This broad eligibility ensures that a diverse array of institutions and organizations can participate, encouraging cross-sector collaboration in the clinical research landscape. The anticipated timeline for the NOFO includes an estimated posting date of November 11, 2025, and an application due date of February 10, 2026. Awards are expected to be announced by October 1, 2026, with funded projects starting by December 1, 2026. As of now, no pre-application deadlines or required concept papers have been disclosed. The opportunity is marked as "Forecasted," indicating it is in the early engagement stage and not yet open for submissions. Interested applicants are advised to consider potential partnerships and start preparing responsive, high-quality proposals well in advance. For further information, applicants can contact Dr. Yves Rosenberg at the Division of Cardiovascular Sciences, NHLBI, via phone at 301-435-1292 or email at rosenbey@nhlbi.nih.gov. This contact point may offer guidance as applicants prepare for the forthcoming NOFO and associated application process.