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

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.