Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

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Key Information

Due Date: February 10, 2026


Agency: United States Department of Health and Human Services


Source: Federal


Funding Categories:

Funding Amount: Not Specified


Funding Type: Grant


Match Required: No


Status: Forecasted


Contact Info: rosenbey@nhlbi.nih.gov
301-435-1292
Yves Rosenberg, MD, MPH Division of Cardiovascular Sciences National Heart, Lung, and Blood Institute

Overview

The NHLBI intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to develop and implement investigator-initiated single 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. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial.

Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R61/R33 activity code. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO.

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Key Dates

Posted Date: May 9, 2025


Application Due Date: February 10, 2026


Estimated Award Date: Not Specified

Additional Details

Eligible Applicants

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

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