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

National Institutes of Health

This Funding Opportunity Announcement (FOA) supports applications to develop and implement a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. Trials for which this FOA applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015 ). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website .

This FOA will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion FOA that encourages applications for a collaborating Data Coordinating Center ( PAR-22-193 ). The objective of the CCC application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The application should also describe its approaches to increasing community engagement and diversity as well as reducing health inequities and disparities.

Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application.

Deadlines:

Letter of Intent Due Date(s): 30 days prior to the application due date
New Applications: October 11, 2022; Feb 10, 2023; June 13, 2023; Oct 11, 2023; Feb 13, 2024; June 11, 2024; Oct 11, 2024; Feb 11, 2025; June 11, 2025
Renewal / Resubmission / Revision Applications: Nov 10, 2022; March 10, 2023; July 11, 2023; Nov 13, 2023; March 11, 2024; July 11, 2024; Nov 12, 2024; March 11, 2025; July 11, 2025
AIDS Applications: January 11, 2023; May 11, 2023; Sep 11, 2023; Jan 11, 2024; May 10, 2024; Sep 11, 2024; Jan 10, 2025; May 12, 2025; Sep 11, 2025

PAR-22-192 Expiration Date September 12, 2025

Specialties

Medical

Medical - Clinical Science

Eligibility Requirements

Multiple PDs/PIs are allowed on any single application. Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.

ESI applicants can be the PI/PD of an application providing they can show support of investigators with appropriate clinical trials experience (as part of a multiple PI team).ESIs are encouraged to be part of thestudyteamandthey should bebudgeted forsupportat a level appropriate for the role on the project.

This FOA only accepts an application that is part of a collaborative pair of applications. The pair must include one application to this CCC UG3/UH3 FOA plus one application to the companion DCC U24 FOA.