NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
About
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.
The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) is designed for researchers and institutions ready to implement investigator-initiated clinical trials that require enhanced oversight and support. This funding opportunity is ideal for investigators who have developed promising therapeutic approaches and need resources to conduct rigorous, milestone-driven clinical trials. The program supports trials lasting up to 5 years, with options for extended studies of 6-7 years, making it suitable for complex research requiring longer implementation timelines. Mechanistic studies integrated into clinical trials are particularly valued, as they advance understanding of human diseases and facilitate development of future therapeutic modalities. Researchers should apply if they have a well-designed clinical trial protocol that addresses important gaps in NIAID's research mission areas. The cooperative agreement structure provides not only funding but also enhanced oversight to ensure trial success. Both U.S. and international organizations, including foreign components of U.S. institutions, are eligible to apply. This is an excellent opportunity for investigators seeking substantial support to move their clinical research from concept to implementation with rigorous peer review backing.
Funding Facts
● Applications openDeadline
July 5, 2029
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by application cycle - consult NOFO
Deadline
2029-07-05
Grant Type
federal
Application Cycle
Annual cycle with specific deadline
Best For
Researchers with investigator-initiated clinical trials requiring enhanced oversight and mechanistic studies; academic institutions and research organizations
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Frequently Asked Questions
Who is eligible for NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)?
Eligible applicants include U.S. domestic organizations and institutions, as well as foreign organizations and non-domestic components of U.S. organizations. International collaborations and foreign components are permitted. Applicants must have an investigator-initiated clinical trial that is milestone-driven and requires enhanced oversight. For complete eligibility requirements, refer to Section III of the official Notice of Funding Opportunity (NOFO) on the NIH website.
How much funding does NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) provide?
Specific funding amounts vary and are not predetermined in this notice. Award amounts depend on the scope and complexity of your proposed clinical trial. Contact NIAID directly or consult the full NOFO for current funding ranges and budget guidance for your application cycle.
How do I apply for NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)?
Applications are submitted through the NIH's standard grants application process. Your application must propose only one clinical trial. All applications undergo NIH standard peer-review processes, and only meritorious applications will be considered for funding. Visit the official NIAID and NIH websites for detailed application instructions, submission deadlines, and required documentation. Investigators are encouraged to review NIAID's mission and research areas before applying.
What can NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) funding be used for?
Funding supports the implementation of investigator-initiated, milestone-driven clinical trials with enhanced oversight. Grants may support mechanistic studies integrated within clinical trials, which advance understanding of human diseases and support development of future therapeutic modalities. Trials can be supported for 5 years, with options for extended studies lasting 6-7 years. Consult the full NOFO for detailed allowable use of funds and budget categories.
Last updated: July 5, 2026