Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)

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) to support the development and implementation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. These trials may include efficacy, comparative effectiveness, pragmatic, and implementation research. The aim is to align with the NHLBI’s mission and the NIH’s definition of a clinical trial. This funding opportunity is part of a collaborative initiative requiring the concurrent submission of both CCC and Data Coordinating Center (DCC) applications, promoting robust infrastructure and operational efficiency for conducting complex trials. This forecasted opportunity will use a bi-phasic, milestone-driven cooperative agreement mechanism identified under activity codes UG3 and UH3. The UG3 phase covers planning, while the UH3 phase supports implementation, contingent on meeting predefined milestones. This phased structure ensures detailed evaluation of readiness before progressing to full implementation. The CCC is expected to present a sound scientific rationale for the proposed trial, including a comprehensive scientific and operational plan. The scope of the funding is tied to research areas covered under several NIH Assistance Listings, including sleep disorders, cardiovascular diseases, lung diseases, blood diseases, and translational science for heart, lung, blood, and sleep disorders. While the estimated total program funding, award ceiling, and award floor are not disclosed, the forecast gives an estimated post date of July 11, 2025, with applications due by October 13, 2025. Awards are anticipated to be announced by May 1, 2026, with projects beginning by July 1, 2026. Eligible applicants include a broad range of organizations such as state and county governments, public and private institutions of higher education, tribal organizations, public housing authorities, independent school districts, nonprofits with 501(c)(3) status, for-profit organizations including small businesses, and federally recognized tribal governments. No cost-sharing or matching is required for this funding opportunity. This opportunity is currently in forecast status, allowing interested parties sufficient time to establish collaborations and develop responsive proposals. Although applications are not yet being solicited, this advance notice is meant to encourage preparation and partnership development among qualified applicants. Inquiries can be directed to Dr. Yves Rosenberg at the NHLBI, who can be reached at 301-435-0550 or via email at [email protected]. More detailed information will be available upon the official release of the NOFO, projected for July 2025.