Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
OpenUpdated: Oct 30, 2025
Summary
The NHLBI is seeking applications for investigator-initiated single site clinical trials that focus on efficacy, comparative effectiveness, pragmatic, and implementation research, with an emphasis on innovative trial designs. Eligible applicants include independent school districts, higher education institutions, government entities, small businesses, and nonprofit organizations. While applications are not currently being accepted, potential applicants are encouraged to prepare and develop collaborations in anticipation of the upcoming NOFO utilizing the R61/R33 activity code.
Full Description
Description
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.
Eligibility
Eligible applicants
Education
- Independent school districts
- Private institutions of higher education
- Public and state institutions of higher education
Government
- Public and Indian housing authorities
- Federally recognized Native American tribal governments
- County governments
Business
- Small businesses
- For-profit organizations other than small businesses
Nonprofit
- Other Native American tribal organizations
- Nonprofits non-higher education with 501(c)(3)
Additional information
Grantor contact information
Description
rosenbey@nhlbi.nih.gov
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