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

Due Dates: October 13, 2025 (Estimated Application Due Date)

Funding Amounts: Not yet specified; cooperative agreement (UG3/UH3), multi-year, milestone-driven funding expected.

Summary: Supports the development and implementation of a Clinical Coordinating Center for investigator-initiated, multi-site clinical trials in alignment with NIH research priorities.

Key Information: Both a Clinical Coordinating Center and a Data Coordinating Center application must be submitted together for consideration.

Description

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), intends to release a Notice of Funding Opportunity (NOFO) to support the creation and operation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. These trials may include efficacy, comparative effectiveness, pragmatic, and/or implementation research, and must be relevant to the NIH mission and meet the NIH definition of a clinical trial.

This opportunity will use a bi-phasic, milestone-driven cooperative agreement mechanism (UG3/UH3). The CCC will be responsible for presenting the scientific rationale for the proposed trial and providing a comprehensive scientific and operational plan. The NOFO will run in parallel with a companion opportunity for a Data Coordinating Center (DCC), and both applications must be submitted together.

Currently, this is a forecasted opportunity; applications are not yet being solicited. The advance notice is intended to give potential applicants time to develop collaborations and responsive projects.

Due Dates

Estimated Application Due Date: October 13, 2025
Estimated Post Date: July 11, 2025
Estimated Award Date: May 1, 2026
Estimated Project Start Date: July 1, 2026

Funding Amount

Award Amount: Not yet specified; details will be provided in the official NOFO.
Funding Mechanism: Cooperative Agreement (UG3/UH3), bi-phasic and milestone-driven.
Cost Sharing/Matching: Not required.

Eligibility

Eligible applicants include:

State governments
County governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
Public housing authorities/Indian housing authorities
Nonprofits with 501(c)(3) status (other than institutions of higher education)
Private institutions of higher education
For-profit organizations (other than small businesses)
Small businesses

Application Process

This is a forecasted opportunity; the official NOFO is not yet released.
Both a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC) application must be submitted on the same due date for consideration.
The application must include a comprehensive scientific and operational plan for the proposed clinical trial.
The opportunity will use the UG3/UH3 activity code, with milestone-driven funding.

Additional Information

The opportunity is relevant for multi-site clinical trials that align with the NIH research mission.
Trials must meet the NIH definition of a clinical trial (see NOT-OD-15-015).
The NOFO is designed to encourage early collaboration and planning among investigators and institutions.
A companion NOFO (FON-HL-25-018) will be released for the Data Coordinating Center.

External Links

Contact Information

Name	Division/Institute	Email	Phone
Yves Rosenberg, MD, MPH	Division of Cardiovascular Sciences, NHLBI	rosenbey@nhlbi.nih.gov	301-435-0550