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

The Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials funding opportunity is offered by the National Institutes of Health within the U.S. Department of Health and Human Services, specifically aligned with the mission of the National Heart, Lung, and Blood Institute. This program is designed to support the development and execution of a Clinical Coordinating Center responsible for managing complex, multi-site clinical trials initiated by investigators. The initiative emphasizes advancing research in heart, lung, blood, and sleep-related conditions and aligns with broader federal priorities to improve public health outcomes and address disparities in healthcare access and effectiveness. The primary purpose of this opportunity is to fund the infrastructure and coordination required to conduct large-scale, multi-site clinical trials. These trials may include efficacy studies, comparative effectiveness research, pragmatic trials, and dissemination and implementation science studies. The program encourages the use of innovative trial designs, such as adaptive, Bayesian, and platform trials, to enhance efficiency and responsiveness to emerging data. Funded coordinating centers are expected to provide comprehensive scientific and operational leadership, ensuring that trials are conducted rigorously and in compliance with NIH standards. Funding is structured as a cooperative agreement using a bi-phasic UG3/UH3 mechanism, which is milestone-driven and requires successful completion of initial planning phases before transitioning to full implementation. Allowable uses of funds include project management, participant recruitment and retention strategies, data oversight coordination, and dissemination of findings. Applicants must demonstrate a clear and detailed plan for managing trial logistics, achieving enrollment targets, maintaining data integrity, and engaging communities throughout the research process. The program places particular emphasis on strategies that promote inclusion and reduce disparities in health outcomes across diverse populations. Eligibility for this opportunity is broad and includes a wide range of domestic and international entities. Eligible applicants include public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit organizations including small businesses, and various levels of government entities such as state, county, and municipal governments. Tribal governments and organizations, independent school districts, and public housing authorities are also eligible. Foreign organizations may apply directly, and foreign components within U.S. organizations are permitted; however, foreign subawards or subcontracts are not allowed under this funding announcement, in accordance with updated NIH policy. The application process requires the simultaneous submission of both a Clinical Coordinating Center application and a corresponding Data Coordinating Center application under a companion funding opportunity. Applications must include detailed descriptions of the scientific rationale, trial design, operational plans, performance milestones, and community engagement strategies. Applicants are strongly encouraged to consult with NIH scientific contacts prior to submission to ensure alignment with program priorities and compliance with submission requirements. The review process will evaluate the scientific merit, feasibility, and potential impact of the proposed trial, as well as the applicant’s capacity to manage complex, multi-site research. The funding opportunity was posted on March 18, 2026, and remains open for submissions until November 2, 2028. There is no cost-sharing or matching requirement associated with this program. While specific award amounts and the number of awards are not specified in the available information, applicants should anticipate a competitive review process and a structured timeline tied to milestone achievement. The program does not explicitly state award notification timelines or performance periods, but given the cooperative agreement structure, funding is expected to be contingent on meeting predefined milestones throughout the project lifecycle. For additional information or assistance, applicants may contact the Division of Cardiovascular Sciences via the provided NIH email address.

Strong emphasis on detailed operational planning, milestone feasibility, and community engagement strategies aligned with NHLBI priorities