NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01 - Clinical Trial Optional) | PAR 18 561

Opportunity Information: Apply for PAR 18 561

The NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention funding opportunity (PAR-18-561) is a National Institutes of Health program run through the National Institute of Neurological Disorders and Stroke (NINDS) that supports multi-site research aimed at improving outcomes for people at risk of stroke or living with stroke-related disability. It is offered as a U01 cooperative agreement, meaning the award is designed for projects where NIH staff will have substantial involvement in the planning and execution of the work, rather than operating purely as a hands-off grant. The central focus is on clinical research that can meaningfully move the field forward: either exploratory or confirmatory multi-center clinical trials of promising interventions, or biomarker and outcome-measure validation studies that are positioned as immediate stepping-stones into full clinical trials. In practical terms, the FOA is built to help investigators take treatments, prevention strategies, or recovery approaches that have strong rationale and early evidence, and test them rigorously across multiple sites in a coordinated network.

A defining feature of this opportunity is that studies are expected to be conducted within the NIH StrokeNet infrastructure. StrokeNet is a standing national clinical trials network created to make stroke trials faster, more consistent, and more feasible at scale by using shared operations, experienced trial sites, and standardized approaches to recruitment, data capture, and oversight. After peer review, NINDS plans to select and prioritize which of the highest-scoring applications will actually be implemented through StrokeNet, reflecting that the network has finite capacity and that NINDS will emphasize the trials with the strongest scientific merit and potential public health impact. The FOA also signals a broader policy direction: NINDS intends that essentially all NINDS-supported multi-center clinical trials in stroke treatment, stroke recovery, or stroke prevention should run through StrokeNet, and that funding comparable multi-site stroke trials outside the network would be rare and only considered under exceptional circumstances.

Operationally, applicants are not expected to build a trial network from scratch. Instead, successful teams will plug into StrokeNet support structures. The StrokeNet National Coordinating Center (NCC) works with awardees to implement the study efficiently, which typically includes coordinating site activation, supporting regulatory and operational workflows, and helping keep multi-site execution consistent. The National Data Management Center (NDMC) provides statistical and data management support, helping with trial design elements, data systems, analysis planning, and high-quality data handling across sites. Recruitment and on-the-ground protocol execution are supported through StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which helps address one of the most common failure points in stroke trials: enrolling and retaining the right patients within the required timelines while maintaining uniform protocol adherence.

In terms of the science that fits this FOA, it is oriented to stroke prevention, acute treatment, and recovery, including both exploratory trials (often earlier, hypothesis-generating, or designed to refine dosage, timing, feasibility, or target population) and confirmatory trials (more definitive tests intended to provide clear evidence of efficacy and safety). The FOA also explicitly welcomes biomarker or outcome-measure validation projects when they are immediately preparatory to clinical trials. That typically means studies that establish that a biomarker is reliable, clinically meaningful, and fit-for-purpose for a near-term trial, or that validate an outcome measure so it can be confidently used as a trial endpoint or stratification tool. The network is also described as being well-positioned to collaborate with other U.S. and international consortia when larger, definitive trials require broader reach, which matters in stroke research where rare subtypes, narrow time windows, or specialized interventions can make large enrollment targets difficult to meet within a single system.

Eligibility is broad and includes many types of domestic U.S. organizations and government entities, such as state, county, and city governments; special districts; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also notes additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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 even non-U.S. (foreign) entities. Importantly, an applicant does not need to already be part of the existing StrokeNet infrastructure to apply; the intent is to allow strong trial concepts from anywhere to compete, with the expectation that funded projects will then be executed through StrokeNet.

From an administrative standpoint, the opportunity is categorized as discretionary funding, uses the cooperative agreement mechanism, and falls under the health activity category with CFDA (now Assistance Listing) number 93.853. The funding opportunity was created on 2018-01-09, and the original closing date listed in the source information is 2020-07-29. While the provided source fields do not specify an award ceiling or expected number of awards, the FOA language makes clear that selection is not only about scoring well in peer review but also about NINDS prioritization and the practical capacity to run the study in the network. Overall, this program is best understood as a pathway for high-quality, multi-site stroke trials and trial-enabling validation studies to be executed efficiently and consistently using NIH StrokeNet’s established national infrastructure, with the long-term goal of accelerating evidence generation for stroke prevention, acute care, and recovery.

• 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 (U01 - 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 2018-01-09.
• Applicants must submit their applications by 2020-07-29. (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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