NINDS Exploratory Clinical Trials (U01 - Clinical Trial Required) | PAR 21 236

Opportunity Information: Apply for PAR 21 236

The NINDS Exploratory Clinical Trials funding opportunity (PAR-21-236) is a National Institutes of Health (NIH) program designed to support investigator-initiated, exploratory clinical trials that fall within the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). The overall goal is to help researchers launch and run early-stage or exploratory human studies that answer important clinical questions in neurology and stroke, especially where the work can generate the kind of evidence needed to justify larger, later-phase trials. Projects proposed under this announcement need to be clearly aligned with NINDS interests, and applicants are expected to use the NINDS website as a guide for ensuring the proposed trial fits the institute's scope.

This opportunity uses the U01 mechanism, which is a cooperative agreement. In practical terms, that means the project is still led by the investigator, but NIH (and specifically NINDS program staff) typically have a more active role than they would under a standard research project grant. Cooperative agreements often involve substantial scientific or programmatic involvement from the funding institute during the life of the award, such as input on study milestones, oversight expectations, coordination requirements, or other elements meant to strengthen trial quality and accountability. The FOA is categorized as a discretionary funding opportunity and falls under the health funding activity category, with CFDA number 93.853.

The clinical trials supported by this FOA can evaluate a broad range of interventions relevant to neurological disorders and stroke. That includes drugs and other pharmacologic agents, biologics, and medical devices, as well as non-pharmacologic approaches such as surgical procedures, behavioral interventions, and rehabilitation therapies. The key idea is that these are exploratory trials, so the focus is commonly on questions like feasibility, initial safety signals, dose or parameter exploration, proof-of-concept, early evidence of target engagement, or preliminary clinical outcomes that can inform whether and how a larger definitive trial should proceed. Because it is explicitly labeled "Clinical Trial Required," applicants must be proposing a study that meets NIH's definition of a clinical trial, meaning there is prospective assignment to an intervention and an evaluation of effects on health-related biomedical or behavioral outcomes.

Eligibility is broad and includes many types of domestic organizations as well as certain non-domestic entities. Eligible applicants listed for this announcement 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; Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations with 501(c)(3) status; nonprofits without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. In addition, the FOA explicitly highlights other 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This range is intended to encourage broad participation across sectors and geographies, including institutions serving historically underrepresented communities.

From the source details provided, the FOA was created on 2021-05-07 and lists an original closing date of 2022-05-07. The award ceiling and expected number of awards were not specified in the provided excerpt, which generally means applicants would need to consult the full announcement and any linked NINDS guidance to understand typical budget expectations, recommended project scale, and the likely range of awards. Overall, the opportunity is best understood as a pathway for investigators to test promising interventions or strategies in human participants within neurology and stroke, with the structure and oversight of a U01 cooperative agreement to support rigorous, well-managed exploratory clinical trial execution.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials (U01 - Clinical Trial Required)" 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 2021-05-07.
• Applicants must submit their applications by 2022-05-07. (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.

Apply for PAR 21 236

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