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

The Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials is a funding opportunity reissued by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) under the Department of Health and Human Services. This cooperative agreement (U24) supports the creation of a Data Coordinating Center (DCC) to accompany a Clinical Coordinating Center (CCC) in executing multi-site clinical trials. These trials are designed to address efficacy, comparative effectiveness, pragmatic, or implementation research in areas aligned with NHLBI’s mission, including trials using innovative methodologies such as adaptive and platform designs. The DCC will play a central role in data management, statistical analysis, regulatory compliance, and oversight for the proposed clinical trial. It will ensure rigorous trial execution by overseeing participant safety, randomization, data quality, and dissemination of results. The DCC must work collaboratively with the CCC and provide support for community engagement efforts outlined in the CCC application. Both the DCC and CCC applications must be submitted on the same date for consideration. The DCC project is milestone-driven and may last up to seven years, though five years is typical. Funding is contingent on meeting performance-based milestones, and administrative reviews will be conducted approximately nine months into the award. Applications must reflect a clear plan for trial management, including project risk assessment and mitigation strategies. Applicants should have a strong background in multi-site trial management, data analytics, and project coordination. A multidisciplinary team is expected to be detailed in the application, and collaboration with the CCC must be evident. A trial management plan and a summary of prior clinical trial experience are required submission components. Milestones for each trial phase must be specified, including site activation, participant recruitment, protocol finalization, and data dissemination. Eligibility is broad, encompassing higher education institutions, nonprofits, for-profit organizations, tribal governments, and certain foreign entities. Applicants must complete various registrations, including SAM, eRA Commons, and Grants.gov, and are advised to begin this process early. Submissions requesting more than $500,000 in direct costs in any year require prior approval from NHLBI. Applications must include a comprehensive budget, synchronization with the CCC, and support for community engagement and regulatory compliance. Applications will undergo a thorough peer review process assessing scientific merit, significance, innovation, and approach. Reviewers will evaluate the capacity of the DCC to support the CCC effectively, the qualifications of key personnel, and the feasibility of proposed timelines and budgets. Applications must demonstrate inclusivity across demographics, detailed data management protocols, and adherence to NIH policies on human subject protections and data sharing.