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NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

National Institutes of Health

posted

Award ceiling

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Award floor

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Posted

Jun 16, 2026

Closes

Jul 5, 2029

Location eligibility

No specific state restriction found in this listing — check the full opportunity for details.

Categories: Health

Eligible applicants: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, County governments, Public and State controlled institutions of higher education, Special district governments, Public housing authorities/Indian housing authorities, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal governments (Federally recognized), City or township governments, Independent school districts, Small businesses, State governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Private institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments), For profit organizations other than small businesses

Description

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

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