NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required)

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Description

This opportunity invites applications for the implementation of investigator-initiated, multi-site interventional clinical trials (all phases) that are hypothesis-driven, milestone-defined, and directly related to the research mission of the National Institute on Aging (NIA). The goal is to advance biomedical, social, and behavioral research that improves understanding of the aging process and addresses diseases, special problems, and needs of older adults.

Proposed trials must be ready for immediate implementation at the time of award, with all planning activities completed prior to submission. The NIA expects that funded trials will be efficiently conducted, appropriately powered, and designed to answer significant research questions relevant to aging. The findings—whether positive or negative—should be published in a timely manner to inform the scientific community and guide future research.

Note: This opportunity is for multi-site clinical trials only. Single-site trials should be submitted under the NIH Parent R01 Clinical Trial Required announcement.

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Due Dates

• June 5, 2025: New applications
• July 5, 2025: Renewal, resubmission, and revision applications (as allowed)
• October 5, 2025: New applications
• November 5, 2025: Renewal, resubmission, and revision applications (as allowed)

All applications are due by 5:00 PM local time of the applicant organization. Additional cycles may be available; see the NIH standard due dates for details.

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Funding Amount

• Budget: No specific budget limit; budgets must be well-justified and reflect the actual needs of the proposed project.
• Project Period: Up to 5 years.
• Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

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Eligibility

Eligible organizations include:

• Public/State controlled and private institutions of higher education
• Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments (federally recognized and other)
• Native American tribal organizations (other than federally recognized)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities (foreign organizations)
• Eligible agencies of the federal government

Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD/PI(s) may apply.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov using ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
• Required Registrations: Applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov. Registration can take 6 weeks or more.
• Application Guide: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
• Forms: Use the SF424 (R&R) application package, including all required attachments (e.g., Research Strategy, Data Management and Sharing Plan, Human Subjects and Clinical Trials Information).
• Budget: Provide a detailed budget reflecting the full scope of the trial, including monitoring, regulatory, quality management, and safety oversight costs.
• Contact: Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

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Additional Information

• Clinical Trial Definition: Applications must meet the NIH definition of a clinical trial: a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects on health-related biomedical or behavioral outcomes.
• Data Management: All applications must include a Data Management and Sharing Plan.
• CROMS: Awardees are expected to interface with the NIA Clinical Research Operations Management System (CROMS) for data management and oversight.
• Review Criteria: Applications will be evaluated for significance, innovation, rigor, feasibility, investigator expertise, and environment, with special attention to relevance for older adults and issues such as multimorbidity and polypharmacy.
• Publication: Timely publication of results is expected, regardless of outcome.
• Human Subjects: All human subjects protections and regulatory requirements apply.

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External Links

• Full Funding Announcement (PAR-25-222)
• NIA Research Mission
• NIH Standard Due Dates
• NIH How to Apply - Application Guide
• NIH Data Management and Sharing Policy
• NIA Clinical Research Operations Management System (CROMS)
• NIH Clinical Trial Definition
• Research Methods Resources

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Contact Information

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