Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) FOR-HL-25-018

The National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), is forecasting the release of a funding opportunity titled “Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)” under the opportunity number FOR-HL-25-018. This grant falls under the cooperative agreement funding mechanism and is specifically categorized under the health sector. NHLBI’s mission supports research aimed at preventing and treating heart, lung, and blood diseases, and sleep disorders. As part of its broader objectives, this opportunity seeks to bolster multi-site clinical trials that are investigator-initiated and aligned with NHLBI's clinical research interests. The primary purpose of this funding opportunity is to solicit applications for a Data Coordinating Center (DCC) that will collaborate with Clinical Coordinating Centers (CCCs) on investigator-initiated clinical trials. These trials may encompass various formats, including efficacy studies, comparative effectiveness trials, pragmatic clinical trials, and implementation research. All proposed clinical trials must adhere to the NIH definition of a clinical trial and align with NHLBI’s research mission. This DCC opportunity is intended to ensure robust data management, statistical support, and overall coordination across multi-site trials. Applicants must submit both DCC and CCC proposals simultaneously for consideration. This cooperative agreement mechanism, identified by the U24 activity code, emphasizes the collaborative role of the DCC in providing centralized administration, project management, biostatistics, and data coordination for the clinical trials submitted through companion funding opportunity FOR-HL-25-029. Applications are not yet being accepted; this is a forecasted announcement intended to give interested applicants sufficient lead time to plan and form meaningful research collaborations. The expected publication date for the formal Notice of Funding Opportunity is November 11, 2025. The projected application due date is February 10, 2026. Awards are anticipated to be made by October 1, 2026, with funded projects beginning on December 1, 2026. The anticipated fiscal year of funding is 2027. This timeline provides over a year of advance notice, allowing potential applicants to engage with prospective collaborators and begin preparation of detailed applications. Eligible applicants for this opportunity include a wide range of organizational types, such as independent school districts, public and private institutions of higher education, small businesses, public housing authorities, Native American tribal organizations and governments, nonprofits with 501(c)(3) status, state and local governments, and for-profit organizations other than small businesses. This broad eligibility aims to encourage a diverse range of applicants with expertise in managing large, multi-site clinical trials. Interested parties are encouraged to monitor Grants.gov and NHLBI communications for updates. For questions or additional guidance, applicants can contact Yves Rosenberg, MD, MPH, in the Division of Cardiovascular Sciences at NHLBI via email at rosenbey@nhlbi.nih.gov or by phone at 301-435-0550.