NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01) | PAR 17 277

Opportunity Information: Apply for PAR 17 277

The NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01) opportunity (PAR-17-277) is designed for research teams that want to run multi-site stroke studies but need an established national clinical trial platform to do it efficiently. Rather than primarily funding a stand-alone, single-site effort, this announcement focuses on granting investigators access to the NIH StrokeNet infrastructure so they can launch and execute well-designed exploratory or confirmatory clinical trials, or complete biomarker and outcome-measure validation studies that are immediately ready to feed into a clinical trial. The overall goal is to speed up the development and testing of interventions that prevent stroke, treat acute stroke, and improve recovery after stroke, while improving the quality and consistency of measures used in these trials.

A central feature of this program is the ability to plug into a ready-made, coordinated network built specifically for stroke research. Applicants whose projects are selected gain operational support from key StrokeNet components: the National Coordinating Center (NCC) helps implement the study efficiently across the network, the National Data Management Center (NDMC) provides statistical support and data management, and the Regional Coordinating Centers (RCCs) along with their affiliated clinical sites support participant recruitment and retention and carry out on-site protocol procedures. In practical terms, this structure is meant to reduce start-up friction, improve consistency across sites, and make it more feasible to recruit enough participants for rigorous multi-site studies, which is often the major barrier in stroke trials.

Projects considered under this FOA include multi-site clinical trials at different stages (exploratory trials that test promising interventions and confirmatory trials that more definitively evaluate efficacy and safety), as well as biomarker or outcome-measure validation studies that are positioned as immediately preparatory to clinical trials. That emphasis on being "immediately preparatory" matters: the intent is not general biomarker discovery or early observational work, but rather validation and standardization efforts that can be used right away to strengthen upcoming or near-term trials in stroke prevention, treatment, and recovery.

Selection is competitive and driven by peer review, but the FOA also makes clear that NINDS will prioritize, among the highest-scoring applications, which trials will actually be conducted within the NIH StrokeNet infrastructure. This indicates a two-layer decision process: scientific merit and readiness are assessed through review, and then NINDS makes a programmatic decision about which of the top applications best fit network capacity and NINDS priorities for stroke research.

Eligibility is broad and intentionally inclusive, reflecting the public health importance of stroke and the need for diverse institutional participation and study populations. Eligible applicants include many types of U.S. governmental entities (state, county, city/township, special districts), public and private institutions of higher education, independent school districts, Native American tribal governments (federally recognized), tribal organizations (including those other than federally recognized tribal governments), public housing authorities/Indian housing authorities, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. The FOA also explicitly highlights additional eligible groups 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, regional organizations, and U.S. territories or possessions. Importantly, non-U.S. entities (foreign organizations and foreign institutions) are eligible to apply, but non-domestic components of U.S. organizations are not eligible. At the same time, foreign components (as defined in NIH policy) are allowed, which means a U.S.-based applicant may be able to include certain foreign elements in the project if they meet NIH definitions and requirements.

Administratively, this is an NIH discretionary grant opportunity within the health category (CFDA 93.853) managed under the National Institutes of Health, with NINDS as the institute connected to prioritization for StrokeNet use. The listing provided includes an original closing date of January 23, 2018 and a creation date of May 10, 2017, which is helpful context for timing and suggests the need to verify current availability or any reissued/replaced announcements if someone is looking to apply now. The notice does not specify an award ceiling or expected number of awards in the provided excerpt, reinforcing that the defining "resource" is access to StrokeNet infrastructure and centralized coordination rather than a simple, fixed funding amount described in the summary.

In short, this X01 opportunity is best understood as a pathway for qualified investigators to run high-quality, multi-site stroke clinical trials or trial-ready biomarker/outcome validation studies using NIH StrokeNet. It aims to accelerate stroke research by giving selected teams an operational backbone for recruitment, site management, protocol execution, and data/statistical coordination, while allowing NINDS to focus network capacity on the most competitive and mission-aligned studies.

• 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 Infrastructure Resource Access (X01)" 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 2018-01-23. (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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