NINDS Efficacy Clinical Trials (U01) - Clinical Trial Required | PAR 18 422

Opportunity Information: Apply for PAR 18 422

The NINDS Efficacy Clinical Trials (U01) funding opportunity (PAR 18 422) is a National Institutes of Health (NIH) discretionary grant program that supports investigator-initiated clinical trials designed to test the efficacy of interventions relevant to neurological disorders and stroke. The central goal is to move beyond early feasibility work and directly evaluate whether a treatment works under controlled clinical trial conditions, focusing on questions that fall within the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). Projects proposed under this announcement must be clinical trials, meaning applicants are expected to prospectively assign human participants to one or more interventions and measure health-related outcomes to determine the intervention's efficacy.

This announcement is specifically intended for efficacy studies and is broad in the types of interventions it will consider, as long as they align with NINDS interests. Proposed trials may evaluate drugs and other therapeutics, biologics, and medical devices, and they may also examine surgical approaches, behavioral interventions, and rehabilitation therapies. In practical terms, the FOA is meant to enable well-justified, scientifically rigorous trials that can answer decisive questions about clinical benefit in neurological conditions, including the kinds of studies that could change clinical practice, support later-stage development, or clarify whether a promising approach should or should not move forward.

The funding mechanism is a U01 cooperative agreement, which typically indicates substantial scientific and/or programmatic involvement by the NIH institute staff compared with a traditional research project grant. While investigators still lead the study, a cooperative agreement usually comes with closer coordination with NINDS on elements such as trial milestones, performance expectations, and oversight structures appropriate for human subjects research. The activity category is Health, and the listed CFDA number is 93.853, which corresponds to NINDS-related NIH assistance.

Eligibility is intentionally expansive and includes a wide range of organizations that might be capable of running an efficacy clinical trial. Eligible applicants include state, county, city or 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status) that are not institutions of higher education; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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 breadth signals NINDS interest in attracting strong trial teams wherever they are based, provided they can meet U.S. federal requirements for clinical research and can credibly execute the proposed study.

From the source details provided, the opportunity was created on 2017-11-29, and the original closing date listed is 2021-05-07. No award ceiling or expected number of awards is specified in the provided data, which often means applicants should consult the full FOA text and NINDS guidance for budget expectations, allowable costs, and any typical funding ranges or constraints. Anyone considering this opportunity is also directed to review NINDS mission and research interest areas on the NINDS website (http://www.ninds.nih.gov/) to ensure the clinical question and target condition fit the institute's priorities.

In short, this FOA supports carefully designed, investigator-led efficacy clinical trials in neurology and stroke across a wide range of intervention types, using the U01 cooperative agreement mechanism, and it is open to a diverse set of eligible organizations, including academic, nonprofit, governmental, tribal, community-based, for-profit, and international applicants, as well as U.S. territories and specialized minority-serving institutions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Efficacy 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 2017-11-29.
• Applicants must submit their applications by 2021-05-07. (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 18 422

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