Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
National Institutes of Health (NIH)
Funding amounts are not limited but should reflect the actual needs of the proposed project.
UG3 phase duration is up to 1 year; UH3 phase duration is expected to be 4 years, with a possibility of up to 6 years with strong justification.
To develop and implement a Clinical Coordinating Center for multi-site clinical trials.
Focus on trials relevant to the research mission of the NHLBI, including innovative designs and addressing health disparities.
National Heart, Lung, and Blood Institute (NHLBI)
Participants in clinical trials, including diverse populations.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local/state/county governments, and tribal governments.
Foreign organizations are also eligible to apply.
Open to U.S. and non-U.S. entities, including foreign organizations.
Must propose clinical trials that meet NIH definitions and are relevant to NHLBI's mission.
Trials must include multi-site recruitment and address community engagement.
No specific budget limits, but budgets must reflect actual project needs.
Direct costs of $500,000 or more require prior consultation with NIH.
Applications are due by September 11, 2025.
UG3 phase expected to start by February 11, 2025.
Applicants may submit multiple applications as long as they are scientifically distinct.
Applications must be part of a collaborative pair with a DCC application.
Applications must include a Trial Management Plan, Clinical Trial Research Experience, and a Community Engagement Plan.
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications undergo peer review and are evaluated for scientific and technical merit.
Applications that address health disparities and include diverse participant recruitment will be prioritized.
Must collaborate with a Data Coordinating Center (DCC) application.
Meeting recruitment and retention milestones is critical for funding continuation.
Encouraged to leverage existing clinical trial networks.
Strong emphasis on community engagement may provide a competitive edge.
Demonstrating experience in multi-site clinical trials and effective project management.
Failing to meet core milestones and not addressing community engagement adequately.
Engage with NHLBI staff early in the application process for guidance.
Highlight innovative trial designs and community engagement strategies.