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

The National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI), has reissued its Funding Opportunity Announcement (FOA) PAR-27-013 to support the establishment and operation of a Data Coordinating Center (DCC) for multi-site investigator-initiated clinical trials. These trials must align with the NIH’s clinical trial definition and NHLBI’s mission to improve public health through research in cardiovascular, lung, blood, and sleep disorders. The DCC, funded under the U24 cooperative agreement mechanism, plays a crucial role in data management, statistical analysis, protocol implementation, and ensuring the integrity of the trial data in collaboration with a Clinical Coordinating Center (CCC) applying under the companion FOA (PAR-27-012). Applications under this DCC FOA must be submitted concurrently with a CCC application for coordinated review and consideration. The purpose of this FOA is to fund applications that support clinical trials addressing efficacy, effectiveness, pragmatic, and implementation research, including adaptive and innovative designs like platform or Bayesian trials. These trials may target therapeutic, behavioral, and/or prevention strategies and must be relevant to NHLBI's strategic goals. Funding will be milestone-based and performance-driven. The DCC’s responsibilities include overseeing trial logistics, project coordination, data quality control, compliance with safety monitoring requirements, and working with the CCC to implement community engagement plans. The design and management strategy should be informed by the NHLBI’s Compendium of Best Practices for Data Coordinating Centers. Award applicants must propose two project phases: the first year aligns with the CCC’s UG3 development phase, covering activities such as protocol finalization, regulatory approvals, data management systems, and trial site activation. The second phase corresponds to the UH3 trial implementation phase, contingent on successful UG3 milestone completion. Funding beyond the UG3 phase will depend on administrative review and NHLBI approval, including assessments of milestone achievement and funding availability. Trials involving investigational drugs or devices must secure FDA approvals (IND/IDE) and submit evidence to NHLBI before award consideration. Trials must begin enrollment by the end of year one. The maximum project duration is 5 years, extendable to 7 years with strong justification. While there is no budget cap, applicants must request funding commensurate with project needs, including support for DSMB activities, community engagement, dissemination, and data sharing. NIH expects the DCC to manage all logistical aspects, including risk contingency planning, trial site coordination, statistical design, and secure IT infrastructure. Budget narratives must align with the CCC budget and detail third-party contributions if applicable. Eligible applicants include domestic and foreign entities such as higher education institutions, nonprofits, small and for-profit businesses, local/state/federal governments, tribal organizations, and public housing authorities. However, NIH prohibits awards to entities involving foreign subawards or subcontracts unless the FOA is explicitly designated for international collaborations. Registration in SAM.gov, eRA Commons, and Grants.gov is required before submission. All PD/PIs must have appropriate NIH eRA Commons credentials, and applicants are advised to engage with NHLBI staff at least 12 weeks before submission to confirm program fit and scope. Applications must follow all instructions in the NIH Application Guide and include specific attachments: a Trial Management Plan, Clinical Trial Research Experience table, and optionally a Network Description if leveraging existing networks. Reviewers will assess significance, investigator qualifications, innovation, approach, and environment, as well as milestone relevance and study feasibility. The DCC must collaborate closely with the CCC and NHLBI throughout the project’s lifecycle, including data sharing per NHLBI policies. Applications are due multiple times annually through November 2028, with reviews following NIH's standard peer review and advisory council processes. Awards may begin as early as April 2027 for the June 2026 submission.

Applicants should plan carefully for milestones and consult with NHLBI at least 12 weeks before submission.