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

The NHLBI intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. 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 cooperative agreement mechanism of award and runs in parallel with a companion NOFO (FON-HL-25-029) that encourages applications for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. Both a DCC application and a collaborating CCC 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 U24 activity code. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO.