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

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), is reissuing a funding opportunity titled "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials." This grant program is intended to support the design and execution of Clinical Coordinating Centers (CCCs) for investigator-initiated, multi-site clinical trials that meet the NIH’s definition of a clinical trial and are relevant to NHLBI’s mission. The funding mechanism is a bi-phasic cooperative agreement award (UG3/UH3) that begins with a development phase and transitions to full trial implementation upon successful completion of milestone-based objectives. Companion funding for a parallel Data Coordinating Center (DCC) under PAR-27-013 is required, and both applications must be submitted together. The scope of supported trials includes those testing therapeutic, behavioral, dissemination, implementation, or prevention strategies. The NIH encourages the use of innovative trial designs, such as platform, adaptive, and Bayesian models. These studies should aim to improve health outcomes across diverse U.S. populations and reduce disparities. A distinguishing feature of this program is its emphasis on rigorous project planning, milestone completion, and efficient administration. Applicants must submit comprehensive operational and scientific plans, including strategies for recruitment, site activation, community engagement, and dissemination of results. Specific attention must be given to inclusion goals across sex, race, ethnicity, age, and other demographics. The UG3 phase may last up to one year and is expected to include protocol finalization, IRB and DSMB approvals, trial site training, and initial participant recruitment. Applicants must demonstrate feasibility and submit evidence of their readiness to transition into the UH3 phase, which may span four to six years depending on justification. NHLBI will conduct a milestone review near the 9-month mark of UG3 to determine eligibility for progression into UH3. Key metrics such as recruitment benchmarks, site activation, and protocol adherence will influence funding continuation. The funding amount is not capped, and budgets should reflect the actual needs of the project. However, multi-year funding projections and clear cost management plans are required. Awards will depend on NIH appropriations and the quality of submissions. Cost sharing is not mandatory, though if included and peer-reviewed, it will become a condition of the award. Foreign components are allowed, but foreign subawards or subcontracts are not permissible unless submitted under a designated international NOFO. The eligibility pool is broad and includes institutions of higher education, nonprofits, for-profits, and government entities at all levels, including foreign organizations with specific limitations. Applications are accepted on a recurring schedule: June 2, 2026; October 2, 2026; February 1, 2027; and subsequent cycles through 2028. All deadlines fall at 5:00 PM local time. There are no pre-application gating steps such as Letters of Intent. Application submission must follow the NIH ASSIST system or Grants.gov, conform to all standard NIH application instructions, and include a Trial Management Plan, Clinical Trial Research Experience table, and a Community Engagement Plan. Optional materials include a Network Description Plan if leveraging an existing trial network. Scientific review will be conducted by NIH’s Center for Scientific Review with final award decisions made by NHLBI based on peer review scores, funding availability, and alignment with program priorities. Applications are evaluated for significance, innovation, feasibility, expertise, and community engagement. Specific criteria include evidence of equipoise, robust risk management planning, and alignment with NHLBI priorities. The anticipated earliest start date for the first application cycle is April 2027. NHLBI will maintain substantial involvement throughout the award period and expects adherence to NIH’s data management and safety monitoring policies.

Ensure milestone and contingency planning is well-developed; Engage with NIH program contacts at least 12 weeks before submission; Avoid overlap of key personnel between CCC and DCC applications