NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required) | PAR 25 222

Opportunity Information: Apply for PAR 25 222

The NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required), funding opportunity number PAR-25-222, is a discretionary NIH grant program from the National Institute on Aging (NIA) that supports the actual implementation and conduct of investigator-initiated, multi-site, interventional clinical trials across any clinical trial phase. The emphasis is on studies that are hypothesis-driven, meaning the trial is designed to rigorously test clearly stated scientific questions, and milestone-defined, meaning applicants are expected to lay out measurable study progress points that can be tracked over time (for example, site activation targets, enrollment benchmarks, retention thresholds, data quality metrics, or interim operational goals). The trials must align with NIA's research mission, which broadly centers on aging and the health and well-being of older adults, including age-related conditions and factors that influence aging-related outcomes. Applicants are expected to ensure that the trial's scientific aims, target population, outcomes, and intervention strategy fit squarely within NIA priorities as described on the institute's website.

This NOFO is specifically focused on multi-site interventional trials, which generally means the intervention is assigned by the study protocol (rather than observed as part of routine care), and the research is conducted at more than one location to strengthen recruitment, improve generalizability, and increase the robustness of the evidence. Because it is an R01 clinical trial required mechanism, the opportunity is intended for well-developed trials that are ready to be executed, with clear operational plans for coordinating multiple sites, maintaining consistent protocol adherence, handling regulatory requirements, managing data, and monitoring participant safety and study integrity. While the short summary does not list a dollar cap or expected number of awards, the structure signals a standard NIH R01-style implementation award where the quality of the trial design, feasibility of recruitment and retention, strength of the investigative team and coordinating infrastructure, and the rigor of statistical and operational planning are central to competitiveness.

Eligibility is broad and includes many types of domestic organizations and certain non-domestic entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories as specified); for-profit organizations other than small businesses; and small businesses. The NOFO also explicitly calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) organizations. This wide eligibility suggests NIA is open to applications from a range of research, health system, community, and institutional settings, provided they can credibly run a coordinated multi-site intervention trial.

Key administrative details from the listing include the activity category of Health and the CFDA number 93.866, indicating the NIA-related federal assistance program area. The opportunity was created on 2024-11-06, and the original closing date is 2026-01-07. In practical terms, prospective applicants should treat the long lead time as an opportunity to finalize site partnerships, lock down intervention delivery and fidelity plans, confirm recruitment pipelines, build a strong coordinating and data management structure, and ensure that the milestones and governance model for a multi-site trial are realistic and clearly justified.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2024-11-06.
• Applicants must submit their applications by 2026-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 222

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