NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional) | PAR 25 052

Opportunity Information: Apply for PAR 25 052

The NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention opportunity (PAR-25-052) is a National Institutes of Health cooperative agreement designed to move promising stroke science into well-run, multi-site studies using the existing NIH StrokeNet infrastructure. The notice encourages applications that test interventions or generate the evidence needed to support future definitive trials across the stroke continuum, including prevention, acute treatment, and recovery/rehabilitation. A key emphasis is on studies that can realistically be executed across multiple clinical sites and that benefit from a coordinated national network for recruitment, consistent protocol delivery, and high-quality data management.

The scope of supported work includes multi-site exploratory and confirmatory clinical trials, as well as biomarker and outcome-measure validation studies that are immediately preparatory to clinical trials. In practical terms, this means applicants can propose early-stage or mid-stage clinical testing of new or improved interventions, and they can also propose rigorous validation of biomarkers (such as imaging, blood-based, physiologic, or digital markers) or clinical outcomes that will strengthen the design and interpretability of future stroke trials. The NOFO also supports ancillary studies that add scientifically valuable aims to trials already underway within StrokeNet, allowing investigators to leverage ongoing recruitment and data collection to answer additional questions without needing to build a separate trial infrastructure from scratch.

Because this is a cooperative agreement mechanism (UG3/UH3), awardees should expect substantial programmatic involvement from NIH and close coordination with StrokeNet leadership rather than a fully investigator-directed grant relationship. The NIH StrokeNet National Coordinating Center (NCC) will work with successful applicants to implement the study efficiently, including operational planning and network-level coordination. The National Data Management Center (NDMC) will provide statistical and data management support, which is particularly important for ensuring common data standards, high-integrity trial conduct, and consistent analyses across many sites. Recruitment and on-the-ground execution are supported through StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which contribute to participant enrollment, retention, and standardized protocol implementation.

A central feature of this opportunity is that studies are expected to be conducted within NIH StrokeNet, and selection is not only based on peer review scores. After peer review, NINDS will prioritize which of the highest-scoring applications will be conducted in the StrokeNet infrastructure. This means applicants should design proposals that are not just scientifically strong, but also operationally realistic for network-based deployment, with clear recruitment feasibility, strong site implementation plans, and well-defined endpoints and data workflows that align with StrokeNet capabilities.

Eligibility is broad and includes many types of domestic U.S. organizations and governments. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other organizations that meet NIH requirements. The NOFO explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

Foreign eligibility is restricted in a way that matters for planning collaborations. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S.-based applicant may include certain foreign activities or collaborators when adequately justified and compliant with NIH policy, even though the applicant organization itself must be domestic.

Administratively, this opportunity is a discretionary funding program under the NIH, using the cooperative agreement funding instrument. The activity category is health and the CFDA/assistance listing number is 93.853. The opportunity was created on November 20, 2024, and the listed original closing date is November 19, 2026. The award ceiling and expected number of awards are not specified in the provided source, which typically means applicants should rely on the full NOFO for budget expectations and network capacity considerations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2024-11-20.
• Applicants must submit their applications by 2026-11-19. (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 25 052

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