NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01) | PAR 17 274

Opportunity Information: Apply for PAR 17 274

The NIH grant opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)" (Funding Opportunity Number PAR-17-274) is a cooperative agreement designed to support clinical research that can be carried out across multiple sites through the NIH StrokeNet network. The main goal is to move promising stroke-related interventions forward by funding both exploratory and confirmatory clinical trials, along with biomarker or outcome-measure validation studies that are positioned as immediate precursors to clinical trials. In practical terms, the program is aimed at studies that are ready to be implemented in a real-world, multi-center setting and that can generate evidence to improve stroke prevention, acute treatment, and recovery/rehabilitation.

A defining feature of this announcement is that funded projects are expected to operate within the NIH StrokeNet infrastructure rather than as standalone trials. StrokeNet is a national clinical trials network built to speed up stroke research by relying on an established coordinating structure and a set of ready-to-activate clinical sites. After applications undergo peer review, the National Institute of Neurological Disorders and Stroke (NINDS) plans to prioritize which of the top-scoring proposals will actually be run through StrokeNet, meaning that strong scientific merit is necessary but network prioritization is also a key step in determining which trials move forward.

Because this is a U01 cooperative agreement, investigators should expect substantial NIH involvement beyond typical grant oversight. The NIH StrokeNet National Coordinating Center (NCC) is positioned as an operational partner that will work closely with awardees to implement studies efficiently, which can include support for study start-up, regulatory coordination, and harmonizing procedures across sites. In parallel, the National Data Management Center (NDMC) provides statistical expertise and data management infrastructure, supporting the design and execution of analyses as well as secure, standardized handling of trial data. Recruitment and on-the-ground execution are supported through StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which help with participant enrollment and retention and with consistent protocol implementation at each site. Altogether, the opportunity is structured to reduce common bottlenecks in multi-site stroke research by pairing funded investigators with an existing national backbone for trial operations, data, and site performance.

The scientific scope is broad within stroke, spanning prevention, treatment, and recovery. Trials may be exploratory, intended to generate early evidence about a promising intervention, or confirmatory, intended to more definitively test efficacy and safety across a larger and more diverse patient population. The FOA also explicitly welcomes biomarker or outcome-measure validation studies when they are directly and immediately preparatory to trials, signaling interest in tools that can improve trial readiness, patient selection, stratification, monitoring, or endpoint assessment. These preparatory studies are meant to be closely tied to near-term clinical testing rather than long-range basic discovery.

Eligibility is intentionally expansive and includes a wide range of public, private, nonprofit, and for-profit entities. Eligible applicants 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; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, as well as other categories. The announcement also highlights additional eligible applicants 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, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects an intent to draw strong clinical trial concepts from many sectors while leveraging the centralized StrokeNet platform to run the studies.

Administratively, the opportunity falls under the National Institutes of Health, with an activity category in health and a CFDA listing of 93.853. The funding instrument is a cooperative agreement (U01), reinforcing that awardees will be working in a collaborative model with NIH and the StrokeNet coordinating components rather than operating completely independently. The original closing date shown for the opportunity is January 7, 2018, and the record creation date is May 10, 2017. The source information provided does not specify an award ceiling or the expected number of awards, so applicants would typically rely on the full FOA text and NIH guidance for budget parameters and likely funding levels.

Overall, this FOA is best understood as a pathway for investigators to propose stroke clinical trials or trial-ready biomarker/outcome validation studies that can be executed efficiently at scale using the NIH StrokeNet national network. It emphasizes multi-site readiness, operational collaboration, and the expectation that well-scored projects will be further prioritized by NINDS for execution within StrokeNet, with coordinated support for implementation, recruitment, data management, and statistical analysis through the network's established centers.

• 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)" 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 2017-05-10.
• Applicants must submit their applications by 2018-01-07. (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.

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