The National Institutes of Health (NIH) is preparing to solicit applications for the establishment of a Clinical Coordinating Center (CCC) dedicated to multi-site investigator-initiated clinical trials, including efficacy, comparative effectiveness, and implementation research. The objective of this opportunity is to develop a comprehensive scientific and operational plan for the clinical trials that align with the research mission of the National Heart, Lung, and Blood Institute (NHLBI) and meet the NIH definition of a clinical trial. This cooperative agreement will follow a bi-phasic, milestone-driven award mechanism and requires the submission of both a CCC application and a collaborating Data Coordinating Center (DCC) application by the same deadline. Interested applicants can reach out to Dr. Yves Rosenberg at rosenbey@nhlbi.nih.gov or call 301-435-0550 for further information. The estimated synopsis post date is July 11, 2025, with applications expected to close on October 13, 2025, and awards anticipated by May 1, 2026.

The NHLBI intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to develop and implement a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. 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). This NOFO will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO (FON-HL-25-018) that encourages applications for a collaborating Data Coordinating Center. The objective of the CCC application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI.Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the UG3/UH3 activity code. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO.

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