NeuroNEXT Clinical Trials (U01) | Apply Online

Opportunity Summary:

The NeuroNEXT Clinical Trials (U01) funding opportunity (PAR 11-343) is a National Institutes of Health cooperative agreement designed to speed up early-to-mid stage clinical research in neurological disorders by plugging investigators into the existing NeuroNEXT clinical trials network. The program focuses on studies that can generate the kind of practical, decision-making evidence needed to justify and properly design a later, definitive Phase III efficacy trial. In other words, it is aimed at trials that reduce uncertainty before a large confirmatory trial is launched, either by validating biomarkers or by testing treatments in an exploratory way that clarifies feasibility, target engagement, dosing, outcomes, and signals of clinical activity in neurologic disease.

The FOA specifically encourages two broad types of projects. First are biomarker validation trials, which are meant to evaluate whether a biomarker is reliable and meaningful enough to support future therapeutic development and trial design (for example, helping select patients, demonstrating target engagement, tracking disease progression, or serving as a pharmacodynamic readout). Second are exploratory clinical trials of interventions such as drugs, biologics, surgical therapies, or medical devices. These studies are not framed as final proof-of-efficacy trials; instead, they are intended to produce the groundwork data that makes a later Phase III trial scientifically and operationally credible.

For drug or biologic proposals, the announcement emphasizes the need for compelling scientific justification that the investigational product will reach and act on its intended target in humans, or that its mechanism of action is reasonably expected to improve a specific aspect of the neurologic disease being studied. This reflects a translational focus: applicants are expected to show that the therapy is not only interesting in principle, but also biologically plausible and testable in a clinical setting with clear rationale linking mechanism to measurable outcomes.

Disease areas selected for study are expected to align with the National Institute of Neurological Disorders and Stroke (NINDS) strategic plan and its clinical research priorities. Applicants are directed to base their choice of disease and research question on those defined interests, which helps ensure that funded trials contribute to NINDS mission goals and to areas where the institute is actively seeking progress.

A central feature of this opportunity is that successful applicants gain access to the NeuroNEXT infrastructure, which is built to make multisite neurological trials faster and more consistent. The NeuroNEXT Clinical Coordinating Center (CCC) supports operational execution of the study, working with awardees to implement the protocol efficiently across the network. The NeuroNEXT Data Coordinating Center (DCC) provides statistical leadership and data management, supporting core functions like database design, data quality control, and analysis planning. NeuroNEXT clinical sites contribute real-world trial capacity, including help with participant recruitment and retention, as well as on-site conduct of the protocol. Importantly, applicants do not need to already be part of the NeuroNEXT network to apply; the model is that strong proposals are brought into the infrastructure rather than limited to pre-existing members.

Administratively, this is a discretionary NIH opportunity using the cooperative agreement mechanism (U01). That means NIH has substantial programmatic involvement compared with a standard investigator-initiated grant, and awardees should expect active collaboration with NIH and the NeuroNEXT coordinating components during planning and execution. The activity category is health research, and the CFDA listing is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost sharing or matching requirement noted in the source information.

Eligibility is broad and includes many types of domestic organizations such as state, local, and tribal governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; independent school districts; public housing authorities; and for-profit organizations (including small businesses and other than small businesses). The eligibility language also explicitly includes a variety of institution types and communities, such as Historically Black Colleges and Universities, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and tribally controlled colleges and universities, along with faith-based and community-based organizations where appropriate. Non-U.S. (foreign) entities and foreign components are allowed as applicants or participants, but they must work with the U.S.-based NeuroNEXT infrastructure, which reflects the network-based nature of the award.

Key dates in the source record show that the opportunity was posted September 21, 2011, with listed closing dates in 2013 and an original closing date in 2014; the record also indicates an archive date in 2013. The full announcement and official requirements are provided through the NIH Grants Guide link associated with PAR 11-343, and NIH’s Office of Extramural Research provides technical support contacts for access or linking issues.

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