NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional) | PAR 24 101

Opportunity Information: Apply for PAR 24 101

The NIH opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)" (PAR-24-101) is a National Institute of Neurological Disorders and Stroke (NINDS) funding announcement that supports research carried out through the NIH StrokeNet clinical trial network. The overall aim is to accelerate high-quality, multi-site studies that can improve stroke prevention, acute treatment, and recovery by leveraging StrokeNet's established infrastructure for coordinating sites, recruiting participants, and managing trial data. Projects are expected to be ready to operate efficiently within a networked, multi-center environment rather than as single-site efforts.

The NOFO encourages several types of studies. First, it supports multi-site exploratory clinical trials that test promising interventions and generate the evidence needed to decide whether a larger, definitive trial is warranted. Second, it supports confirmatory clinical trials intended to more rigorously evaluate the efficacy or effectiveness of interventions relevant to stroke. In addition, the program emphasizes biomarker and outcome measure validation studies when those efforts are immediately preparatory to clinical trials, meaning the biomarker or measure needs to be validated now because it will directly enable or strengthen an upcoming prevention, treatment, or recovery trial. Finally, the NOFO allows ancillary studies, which are add-on scientific aims that can be embedded within active StrokeNet studies to answer additional questions without duplicating infrastructure or launching a completely separate trial.

This funding uses a cooperative agreement mechanism, which signals that NINDS and the StrokeNet infrastructure will have an active role in supporting and overseeing implementation rather than functioning only as a passive funder. After peer review, NINDS plans to prioritize studies among the highest scoring applications for execution within the NIH StrokeNet system. Awardees will work collaboratively with key StrokeNet components: the National Coordinating Center (NCC) helps operationalize and implement the study efficiently across the network; the National Data Management Center (NDMC) provides statistical support along with data management and related trial informatics; and the Regional Coordinating Centers (RCCs) plus their affiliated clinical sites support recruitment and retention and carry out on-site protocol implementation. In practical terms, applicants should anticipate designing protocols that can be standardized across multiple sites, are compatible with centralized data management, and are feasible for recruitment through StrokeNet's participating hospitals and clinics.

Eligible applicants are broad and include many government, academic, nonprofit, and commercial entities. Examples listed 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; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and Native American tribal governments (federally recognized) as well as tribal organizations other than federally recognized tribal governments. The NOFO also explicitly highlights a range of institutions and community-focused organizations as eligible, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

There are important restrictions related to non-U.S. applicants and components. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, which typically means discrete project elements that involve a foreign collaboration can be permitted under NIH rules even though the applicant organization must be U.S.-based and the primary award cannot be made directly to a foreign institution.

The opportunity is categorized as discretionary funding and uses the UG3/UH3 approach, which generally reflects a staged pathway that can support planning or start-up milestones before transitioning to a later phase of implementation, though the NOFO is described as "Clinical Trial Optional." That wording generally means a proposed project may include a clinical trial but does not have to, which fits with the inclusion of biomarker validation and ancillary studies that may be preparatory to trials or embedded within them. The CFDA (Assistance Listing) number provided is 93.853, and the sponsoring agency is the National Institutes of Health. The original closing date listed is 2026-11-19.

In essence, this NOFO is designed for research teams with a strong, trial-ready question in stroke prevention, treatment, or recovery, and a plan that benefits from multi-site execution. Competitive projects will align with StrokeNet capabilities, be operationally feasible across network sites, and clearly justify how the proposed intervention testing, biomarker or outcome validation, or ancillary aims will advance the stroke clinical evidence base in a way that is ready for network deployment.

• 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 2023-12-28.
• 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.

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