Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)

The Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) funding opportunity is administered by the National Institutes of Health (NIH), with specific participation from the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute on Aging (NIA). This opportunity, issued under funding announcement number PAR-23-084, invites applications for milestone-driven, investigator-initiated clinical trials requiring extended project periods of six or seven years. It reissues PAR-20-139 and has been updated as of March 31, 2025, to better align with the agency's strategic priorities. The grant supports clinical trials of any phase, provided they are hypothesis-driven and related to the missions of the participating NIH Institutes and Centers. Eligible studies must be long-term in scope and ready for implementation at the time of application. Clinical trial planning must be complete before submission, and the application must justify the necessity for an extended timeframe. Only one clinical trial may be proposed per application, and multi-year funded awards or planning studies are excluded. A complete clinical protocol is required, and projects must include detailed milestone plans and contingency strategies to address potential delays. Eligible applicants include a wide range of U.S. and foreign institutions, including higher education institutions (both public and private), nonprofits, for-profit organizations (including small businesses), government entities (local, state, and federal), independent school districts, housing authorities, Native American organizations, and regional organizations. Both domestic and non-U.S. institutions may apply, as well as components of foreign institutions. Applications must be submitted electronically via NIH’s ASSIST system, Grants.gov Workspace, or institutional system-to-system solutions. The earliest submission date was April 13, 2023. Applications are accepted on specified cycles throughout the year, with the final submission deadline currently listed as May 24, 2025, due to early expiration notices. There are no requirements for Letters of Intent. All application components, including budget, human subjects protection, and data management plans, must follow the SF424 (R&R) guidelines and adhere to the FORMS-H application package requirements. Evaluation of applications is based on NIH peer review criteria including significance, investigators’ expertise, innovation, approach, and environment. Milestone-based project management is emphasized, and recruitment goals and trial adherence are closely monitored. Awards will be made as standard grants and may be converted to cooperative agreements (U01) if substantial NIH involvement is necessary. The NIH will assess ongoing progress through annual RPPRs and other reporting mechanisms. Programmatic contacts for applicants include Martin Gutierrez and Ellen Goldmuntz at NIAID, and Sergei Romashkan at NIA. Peer review and financial contacts are also available for both institutes. All applicants are encouraged to consult with appropriate NIH staff at least ten weeks before submission to ensure alignment with institute priorities and readiness for implementation.