NINDS Exploratory Clinical Trials (U01 - Clinical Trials Required) | PAR 18 420

Opportunity Information: Apply for PAR 18 420

The NINDS Exploratory Clinical Trials funding opportunity (PAR-18-420) is a National Institutes of Health (NIH) grant mechanism designed to support investigator-initiated, early-stage clinical trials in neurology and related areas covered by the National Institute of Neurological Disorders and Stroke (NINDS). It uses the U01 cooperative agreement format, which generally means the project is still led by the awardee, but NIH/NINDS typically expects a more active partnership than a standard research grant, especially around planning, oversight, and milestone-driven execution. A central requirement is that applications must include a clinical trial, and the proposed study must directly align with the NINDS mission and research priorities.

The program is aimed specifically at exploratory clinical trials, meaning studies that are intended to answer important preliminary questions before a larger, definitive efficacy trial is justified. These trials often focus on feasibility, safety, dosing, proof-of-concept signals, target engagement, preliminary efficacy, biomarker behavior, or optimizing intervention delivery and trial procedures. The opportunity is broad in terms of what kinds of interventions can be tested, as long as the research question fits within NINDS interests. Applicants may propose trials evaluating drugs, biologics, and medical devices, as well as surgical approaches, behavioral interventions, and rehabilitation therapies. In practical terms, this allows a wide range of neurology-focused clinical experimentation, from early human testing of a new device concept to pragmatic testing of a rehabilitation protocol, provided the work remains within NINDS scientific scope.

Eligibility is expansive and includes many types of institutions and organizations. Standard eligible applicants listed include state, county, city, township, and 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; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It further notes eligibility for certain nontraditional or special categories including faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities, which is notable for investigators who may be planning multinational studies or leveraging specialized overseas patient populations or research infrastructure.

From an administrative standpoint, the opportunity is categorized as a discretionary grant in the health funding activity area and is associated with CFDA number 93.853 (NINDS). The funding instrument type is a grant using the U01 mechanism, and because it is explicitly labeled “Clinical Trials Required,” the application must be structured around a real interventional clinical trial rather than observational research only. The public source data provided lists an original closing date of 2021-05-06 and a creation date of 2017-11-29; applicants considering a similar submission today would typically confirm whether the FOA is still active or whether a reissued or updated NINDS clinical trial announcement has replaced it.

Overall, the opportunity is meant to help researchers move promising neurological interventions and therapeutic strategies into early clinical testing, generate high-value data needed to justify larger trials, and do so in areas that match NINDS priorities. The breadth of eligible applicants and intervention types suggests NINDS was aiming to attract a wide pool of investigators and partners, including academic, nonprofit, community-based, tribal, government, and industry participants, so long as the proposed exploratory trial addresses a meaningful NINDS-relevant clinical question.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials (U01 - Clinical Trials 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 2017-11-29.
• Applicants must submit their applications by 2021-05-06. (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 18 420

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