This Funding Opportunity Announcement (FOA) supports 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. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA 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). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.
This FOA will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion FOA PAR-22-192 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. The application should also describe its approaches to collaborate with the CCC on implementation of the clinical trial community engagement and diversity plans.
Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application.
Deadlines:
PAR-22-193 Expiration Date September 12, 2025
Multiple PDs/PIs are allowed on any single application. Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.
ESI applicants can be the PI/PD of an application providing they can show support of investigators with appropriate clinical trial data coordinating experience (as part of a multiple PI team). ESIs are encouraged to be part of the study team and they should be budgeted for support at a level appropriate for the role on the project.
This FOA only accepts applications that are part of a collaborative pair of applications. The pair must include one DCC U24 application to this FOA plus one application to the companion CCC UG3/UH3 FOA.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The combined budgets of the CCC and DCC will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied.
The scope of the proposed project should determine the requested project award period.
The period of award is expected to be 5 years. Up to 7 years may be requested if strongly justified.
