Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

The National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, has forecasted a Notice of Funding Opportunity (NOFO) for a Data Coordinating Center (DCC) to support multi-site investigator-initiated clinical trials. This opportunity is designed to enhance the infrastructure supporting efficacy, comparative effectiveness, pragmatic, and implementation research trials. The trials must align with the NHLBI’s mission and meet the NIH’s definition of a clinical trial as outlined in NOT-OD-15-015. The primary objective of this opportunity is to fund a DCC that will collaborate with a Clinical Coordinating Center (CCC) through a companion NOFO (FON-HL-25-029). The DCC will be responsible for project coordination, administration, data management, and biostatistical support for the clinical trials proposed in the CCC application. Both DCC and CCC applications must be submitted simultaneously for review by NHLBI, as the grants are interdependent. The funding mechanism for this opportunity will be a cooperative agreement using the U24 activity code. Applications for this grant are not currently being solicited. The forecast provides advanced notice to allow sufficient time for potential applicants to develop robust collaborations and comprehensive project plans. The anticipated application open date is July 11, 2025, with applications due by October 13, 2025. The estimated award date is May 1, 2026, and project start date is expected on July 1, 2026. Eligible applicants include a wide range of entities, such as state and county governments, Native American tribal governments and organizations, public and private institutions of higher education, nonprofits with 501(c)(3) status, independent school districts, public housing authorities, and both for-profit and small businesses. There are no matching fund requirements for this opportunity, and cost-sharing is not mandated. While specific funding amounts, including the total available program funding and the range of individual awards (ceiling and floor), have not been announced, applicants are advised to monitor Grants.gov for updates. The NOFO is associated with several Assistance Listings, reflecting its coverage of sleep disorders, cardiovascular, lung, and blood diseases research, and implementation science. The primary contact for this opportunity is Dr. Yves Rosenberg at the Division of Cardiovascular Sciences, NHLBI. He can be reached by phone at 301-435-0550 or via email at rosenbey@nhlbi.nih.gov.