NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed)

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH) under the Department of Health and Human Services (HHS), is offering the NIAID Clinical Trial Planning Grant (R34), a reissue of PAR-20-270. This funding opportunity supports investigator-initiated planning and preparatory activities for clinical trials that align with NIAID's mission, focusing on high-priority research areas within infectious, immunologic, and allergic diseases. Clinical trials must be hypothesis-driven, milestone-defined, and based on adequate pre-clinical data, though this grant does not fund the implementation of trials or the collection of clinical data. The grant supports various planning activities essential for trial readiness, including assembling research teams, selecting enrollment sites, finalizing study design, and developing protocols, consent forms, regulatory strategies, data management and safety monitoring plans, and training materials. Awards are limited to $150,000 in direct costs for a one-year project period, with no allowance for clinical trials or investigational product development. The grant is intended to facilitate early peer review, refine study design, and prepare all documentation required for subsequent trial implementation under other NIH funding mechanisms like R01, U01, or U44. Eligible applicants include a wide range of U.S. and non-U.S. institutions and organizations, such as higher education institutions, nonprofits, for-profit entities, local and state governments, tribal governments and organizations, independent school districts, public housing authorities, and foreign institutions. Applicants must complete all required registrations including SAM, NCAGE, UEI, eRA Commons, and Grants.gov prior to submission. Applications that do not meet the eligibility or submission criteria will not be reviewed. The application process includes submitting a letter of intent 30 days before the due date, though this is not mandatory. Applications must follow the SF424 (R&R) instructions and specific guidance outlined in this Notice of Funding Opportunity. Key application components include specific aims, a detailed research strategy, letters of support, and compliance with human subjects and clinical trials requirements where applicable. Reviewers will evaluate significance, investigator expertise, innovation, approach, and the research environment. Applications are also assessed on additional criteria such as inclusion of diverse populations, use of vertebrate animals, and handling of biohazards. Applications are due by 5:00 PM local time on various dates through May 2026, with reviews and potential award dates staggered accordingly. The next application due date is May 13, 2025. While the funding opportunity is not recurring and does not operate on a rolling basis, the latest expiration date is May 24, 2025, per Notice NOT-OD-25-113. Applicants are strongly encouraged to consult NIAID staff at least ten weeks prior to submission to determine suitability and alignment with the institute’s priorities. For inquiries, potential applicants may contact scientific/research staff such as Ellen Goldmuntz, M.D., at egoldmuntz@niaid.nih.gov, or Martin Gutierrez at mgutierrez@niaid.nih.gov. Peer review and financial questions may be directed to Louis Rosenthal, Ph.D., at louis.rosenthal@nih.gov and Lily Campbell at lily.campbell@nih.gov respectively. Full details are provided in the official Notice of Funding Opportunity PAR-23-206, accessible via NIH platforms and Grants.gov.