Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Funds a Clinical Coordinating Center to lead multi-site clinical trials using innovative designs, focusing on NHLBI’s mission and health outcome disparities.
Funder: National Institutes of Health
Due Dates: November 2, 2028 (Full application deadline; CCC and collaborating DCC must be submitted on the same date)
Funding Amounts: Award ceiling and floor not specified; milestone-driven cooperative agreement; see NOFO for details.
Summary: Supports development and operation of a Clinical Coordinating Center for multi-site, investigator-initiated clinical trials using innovative research designs.
Key Information: CCC and collaborating DCC applications are required and must be submitted together.
Description
This opportunity funds the establishment and management of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. The initiative welcomes trials employing innovative methodologies such as platform, adaptive, and Bayesian designs, and encourages projects in efficacy, comparative effectiveness, pragmatic, and/or dissemination and implementation science. Trials must align with the National Heart, Lung, and Blood Institute (NHLBI) mission and meet the NIH definition of a clinical trial.
The CCC is responsible for developing the scientific rationale and comprehensive operational plan, including project management, recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Applicants should emphasize approaches for community engagement and strategies to address health outcome disparities. The funding mechanism is a bi-phasic, milestone-driven cooperative agreement, and a collaborating Data Coordinating Center (DCC) application must be submitted in parallel.
