Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Neuroprotection (U01 Clinical Trial Not Allowed) | RFA NS 18 033

Opportunity Information: Apply for RFA NS 18 033

The Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Neuroprotection is an NIH-funded cooperative agreement (U01) designed to push promising stroke neuroprotective therapies closer to clinical readiness by strengthening the evidence generated right before human testing. The core idea is to reduce the common drop-off between encouraging early animal data and disappointing clinical trial results by running more rigorous, clinically relevant, late-stage preclinical studies. The focus is specifically on acute neuroprotectants intended to be given prior to reperfusion or at the time reperfusion occurs, reflecting real-world stroke care where reopening the blocked vessel (for example, via thrombectomy or thrombolysis) is central, but additional therapies may be needed to protect brain tissue and improve long-term recovery.

A defining feature of SPAN is the creation of a coordinated preclinical stroke testing network that can evaluate candidate therapies in parallel, using standardized methods and outcomes that better match what matters clinically. Rather than relying on single-lab findings, the network approach is meant to generate more dependable, reproducible results across sites and models, while also making testing faster and more cost-effective than repeating isolated studies one by one. The program emphasizes experimental designs that include clinically relevant long-term outcomes (not just short-term infarct size or early neurological scores) and that incorporate comorbidities that are common in real patients and often ignored in traditional preclinical work. By embedding these real-world factors into controlled experiments, SPAN aims to clarify whether a neuroprotective intervention truly adds benefit beyond reperfusion alone and whether it can extend the time window in which reperfusion remains beneficial.

The initiative also highlights the use of an adaptive design approach in preclinical testing. In practical terms, that means the network is intended to make data-driven adjustments as evidence accumulates, helping prioritize the most promising therapies and discontinue unpromising ones sooner. The goal is not simply to run more experiments, but to run smarter experiments that can efficiently distinguish which candidates are most likely to translate to patient benefit. This is framed as a translational bridge: late-stage preclinical work that is closer in spirit to the rigor and relevance expected of clinical development, while still being conducted in an experimental, tightly controlled setting.

Administratively, this opportunity is issued by the National Institutes of Health under Funding Opportunity Number RFA-NS-18-033, within the health research activity category (CFDA 93.853). The award mechanism is a cooperative agreement (U01), which generally indicates substantial NIH scientific or programmatic involvement compared to a standard research project grant. The opportunity is explicitly labeled “Clinical Trial Not Allowed,” signaling that funded activities must remain in the preclinical domain rather than enrolling human participants in interventional clinical studies.

Eligibility is broad across U.S.-based organizations and includes many types of government entities (state, county, city or township, special districts), public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, and public housing authorities/Indian housing authorities. It also includes federally recognized Native American tribal governments and other Native American tribal organizations, as well as nonprofits (both with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. The announcement also calls out 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, regional organizations, eligible federal agencies, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, the program draws a firm boundary around foreign involvement: non-U.S. entities and foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

In short, SPAN is aimed at building a rigorous, network-based preclinical pipeline to identify which acute neuroprotective therapies truly improve meaningful outcomes when paired with reperfusion, and to do so using study designs and patient-like conditions that increase the odds of successful translation to the clinic, without funding human clinical trials under this specific opportunity.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Neuroprotection (U01 Clinical Trial Not Allowed)" 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 2018-08-06.
• Applicants must submit their applications by 2018-12-13. (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 RFA NS 18 033

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