NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional) | PAR 18 563

Opportunity Information: Apply for PAR 18 563

The NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention opportunity (PAR 18-563) is a National Institutes of Health funding announcement designed specifically for U.S. small business concerns applying through the Small Business Innovation Research (SBIR) program. It supports projects aimed at advancing new and promising approaches for stroke prevention, acute treatment, and recovery. The core emphasis is on human studies that either test interventions in clinical trials or validate biomarkers and outcome measures that are ready to be used in near-term clinical trials. In practical terms, the program is meant to help small companies move a stroke-related product, therapy, device, diagnostic, or measurement tool from a strong scientific rationale into well-run clinical evaluation.

A key feature of this announcement is that it uses a cooperative agreement mechanism (U44), which means NIH involvement is more active than in a standard grant. The projects are expected to be milestone-driven, with clear go or no-go decision points and agreed-upon deliverables that keep the work on track and support efficient study execution. This structure is intended to reduce common clinical research bottlenecks, such as slow site activation, inconsistent data processes, and recruitment delays, while also giving NIH a stronger role in coordinating complex, multi-site stroke studies.

The scope includes both exploratory and confirmatory clinical trials for stroke-related interventions. Exploratory trials generally focus on early evidence of safety, dosing, feasibility, or preliminary signals of efficacy, while confirmatory trials are more focused on rigorously testing whether an intervention works under well-controlled conditions. Alongside trials, the FOA also encourages biomarker or outcome measure validation studies that are immediately preparatory to trials. That phrasing matters: the validation work should be close to trial-ready, such as demonstrating that a biomarker is reliable, clinically meaningful, and operationally feasible across sites, or that an outcome measure is sensitive and standardized enough to serve as a trial endpoint in stroke populations.

What makes this opportunity distinctive is that successful projects are expected to be conducted within the NIH StrokeNet infrastructure, a national network built to run stroke clinical studies more efficiently and consistently across many clinical sites. After peer review, the National Institute of Neurological Disorders and Stroke (NINDS) plans to prioritize which of the highest-scoring applications will be supported specifically within StrokeNet, reflecting the reality that network resources are coordinated and finite. If selected, the small business does not operate alone; it collaborates with StrokeNet’s coordinating and data centers as well as clinical sites that already have stroke expertise and research-ready capabilities.

StrokeNet’s components play defined roles that applicants should understand when planning a project. The National Coordinating Center (NCC) works with awardees to implement the study efficiently, which can include operational planning, site coordination, and study start-up support. The National Data Management Center (NDMC) provides statistical and data management support, which typically covers database development, data quality oversight, and statistical input needed for rigorous trial conduct. Regional Coordinating Centers (RCCs) and their affiliated clinical sites support patient recruitment and retention and handle on-the-ground implementation of the clinical protocol, meaning enrollment, study visits, intervention delivery (as applicable), and clinical data collection occur within an established network of stroke trial sites.

Another important element is scalability. StrokeNet is positioned not only to run the studies funded under this FOA, but also to connect with other U.S. and international consortia when larger, definitive trials are needed. This matters for small businesses because it can create a more realistic pathway from early clinical evidence to the kind of large, multi-center validation that regulators, clinicians, and payers often expect before widespread adoption.

Eligibility is limited to small businesses, consistent with SBIR requirements. Foreign (non-U.S.) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components as defined under the NIH Grants Policy Statement may be allowed in certain circumstances, which typically means discrete elements of the project could potentially be performed abroad if well-justified and permissible under NIH policy, even though the applicant organization itself must be U.S.-based and eligible as a small business.

From the listing details, this is a discretionary NIH opportunity in the health category (CFDA 93.853) and uses a cooperative agreement funding instrument type. The original closing date shown is April 5, 2021, and no award ceiling or expected award count is specified in the provided excerpt, which usually signals that budget and award volume depend on NIH appropriations, program priorities, and the specific needs and costs of individual studies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials 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 2021-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 18 563

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