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Frequently Asked Questions (FAQs): NeuroNEXT Infrastructure Resource Access (X01) - PAR-11-344

What is the NeuroNEXT Infrastructure Resource Access (X01) opportunity?

The NeuroNEXT Infrastructure Resource Access (X01) opportunity (Funding Opportunity Number PAR-11-344) is a National Institutes of Health (NIH) discretionary grant mechanism intended to give investigators access to the NeuroNEXT clinical research infrastructure. It is designed to support early-stage, well-structured clinical studies in neurologic disease that benefit from a coordinated network, standardized processes, and operational support.

What is the main purpose of this funding opportunity?

The primary goal is to generate practical, decision-making evidence that helps determine whether a larger, definitive efficacy trial (often described as a Phase III trial) is justified and how that larger trial should be designed.

What stage of research is this opportunity meant to support?

This program is meant for projects that are beyond purely preclinical work but not yet at the confirmatory, large-scale stage. It targets early clinical and translational efforts where results can reduce uncertainty before committing to a major efficacy trial.

What kinds of studies does the FOA encourage?

The FOA highlights two main study types: (1) biomarker validation trials and (2) exploratory clinical trials evaluating interventions such as drugs, biologics, surgical therapies, or devices.

What is meant by a biomarker validation trial in this FOA?

Biomarker validation trials are studies aimed at showing that a biomarker is reliable and meaningful enough for use in future neurologic clinical trials. This can include demonstrating analytic performance, clinical relevance, or showing how the biomarker tracks disease activity or treatment response in ways that inform endpoint selection and trial design.

What is meant by an exploratory clinical trial under this FOA?

Exploratory clinical trials under this FOA are intended to evaluate interventions (including drugs, biologics, surgical therapies, or devices) and produce actionable information that can guide later, larger trials.

What types of interventions can be evaluated in exploratory clinical trials?

The FOA explicitly mentions exploratory clinical trials evaluating drugs, biologics, surgical therapies, or devices.

What outcomes or information are exploratory trials expected to generate?

Exploratory trials are expected to produce actionable information such as evidence of target engagement, dose selection guidance, feasibility signals, safety and tolerability in the intended population, early indications of biological or clinical activity, and other parameters that reduce uncertainty before launching a larger confirmatory study.

Does the FOA emphasize anything specific for drug or biologic proposals?

Yes. For proposals involving drugs or biologics, the FOA places particular emphasis on the strength of the underlying scientific rationale. Applicants are expected to provide compelling evidence that the agent can reach and act on the intended biological target in humans, or that its mechanism of action is plausibly tied to improving a specific component of the neurologic disease being studied.

Is this FOA intended for loosely justified repurposing ideas?

No. The description indicates NeuroNEXT is not intended for minimally supported therapeutic hypotheses. Instead, it is aimed at interventions with a credible mechanistic bridge from the agent to the target and from the target to a clinically relevant disease pathway, supported by a study plan capable of producing interpretable results.

What is the NIH program area or catalog listing associated with this opportunity?

This opportunity is categorized under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).

Is cost sharing or matching required?

No cost sharing or matching requirement is stated in the provided source data.

Who is eligible to apply?

The eligibility description is broad and includes for-profit organizations (including small businesses), nonprofit organizations (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status), and other eligible entities described in the announcement.

Are non-U.S. (foreign) organizations allowed to apply?

Yes. Non-U.S. (foreign) organizations and foreign components are allowed, but they must work with the U.S.-based NeuroNEXT infrastructure. This aligns with the FOA’s purpose of facilitating access to a U.S. clinical trial network.

Is this opportunity still open for applications?

No. The timing information indicates the opportunity was posted on September 21, 2011, with an original closing date of October 21, 2014, a current closing date listed as December 30, 2014, and an archive date of January 30, 2015. Based on those dates, this specific FOA cycle is no longer open.

Where was the full announcement posted?

The full announcement was hosted by NIH and referenced via the NIH Grants Guide page at http://grants.nih.gov/grants/guide/pa-files/PAR-11-344.html.

Who should be contacted for access or technical linking issues related to the announcement?

For access or technical linking issues, the contact listed is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

What is the key value of NeuroNEXT mentioned in the description?

The key value described is access to a coordinated clinical research network with standardized processes and operational support, enabling early-stage neurologic studies to be conducted in a structured way that supports decision-making about later definitive trials.

What kind of evidence is this FOA trying to generate for later trials?

The FOA focuses on generating practical, decision-making evidence that can justify whether a larger efficacy trial should happen and shape how it should be designed, including aspects like endpoints, dosing, feasibility, and interpretability.

Does the FOA describe the funding as unrestricted research support?

No. The description emphasizes that the central purpose is facilitating access to the U.S.-based NeuroNEXT clinical trial infrastructure rather than providing unrestricted research funding.