NeuroNEXT Clinical Trials (U01 - Clinical Trial Optional) | PAR 18 528

Opportunity Information: Apply for PAR 18 528

The NeuroNEXT Clinical Trials funding opportunity (PAR 18-528) is a National Institutes of Health cooperative agreement (U01) run through the National Institute of Neurological Disorders and Stroke (NINDS) under CFDA 93.853. It is designed to support exploratory, early-stage clinical studies in neurology that help investigators generate the kinds of evidence needed to justify and properly design a larger, definitive future trial. In practical terms, the program is aimed at studies that answer key "should we move forward and how should we run the next trial" questions, rather than immediately funding a large phase 3-style effectiveness trial.

The FOA specifically encourages clinical trials and related studies involving investigational agents, including drugs, biologics, surgical therapies, and medical devices. The trials supported under this mechanism are intended to produce actionable data such as feasibility and operational lessons, preliminary clinical signals, proof-of-mechanism results (showing the intervention is engaging the intended biological pathway in humans), and biomarker validation evidence. The diseases and conditions proposed for study are expected to align with NINDS priorities, and applicants are directed to ground their choices in the NINDS strategic plan and published clinical research interest areas.

A central feature of this opportunity is that successful applicants gain access to the NeuroNEXT network infrastructure, which is meant to speed start-up and improve execution of multicenter neuroscience trials. After applications go through peer review, NINDS makes additional programmatic decisions by prioritizing and sequencing which recommended trials will actually be slotted into and supported by the NeuroNEXT infrastructure. In other words, a favorable review is necessary but not the only step; NINDS then determines which studies move forward within the network based on priorities and capacity.

Once a project is selected, the applicant does not have to build a full trial enterprise from scratch. The NeuroNEXT Clinical Coordinating Center (CCC) collaborates with the awardee to operationalize and implement the study efficiently, helping with coordination across sites and trial conduct. The NeuroNEXT Data Coordinating Center (DCC) provides statistical expertise and data management support, which typically includes guidance on analysis planning, data capture systems, and oversight of data quality processes. In addition, the NeuroNEXT clinical sites support participant recruitment and retention and carry out on-the-ground protocol execution at their locations, which is often a major bottleneck for early clinical studies.

Eligibility is broad and includes many typical NIH applicant types: state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA also explicitly calls out 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities. Importantly, applicants do not need to already be part of NeuroNEXT to apply, which lowers the barrier for external investigators with strong trial concepts.

From an administrative standpoint, this is a discretionary health funding opportunity using a cooperative agreement, meaning NINDS expects to have substantial involvement in the conduct of the project compared to a standard research grant. The original posting date is listed as 2017-12-21, and the original closing date shown in the source text is 2021-03-05. No award ceiling or expected number of awards is provided in the supplied listing, so applicants would typically need to consult the full FOA for budget expectations, project period limits, and any caps or network-specific cost structures.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NeuroNEXT Clinical Trials (U01 - Clinical Trial 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 2017-12-21.
• Applicants must submit their applications by 2021-03-05. (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 18 528

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