Opportunity Information: Apply for PAR 15 195
Apply for PAR 15 195
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NeuroNEXT Infrastructure Resource Access (X01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Apr 30, 2015 and posted on Apr 30, 2015.
- Applicants must submit their applications by Nov 12, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: 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 Special district governments Private institutions of higher education County governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal governments (Federally recognized) Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses City or township governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NeuroNEXT Infrastructure Resource Access (X01) funding opportunity (PAR 15 195) is a National Institutes of Health program designed to help investigators run early stage, exploratory clinical studies in neurology by giving them access to an established national clinical trials network rather than having them build trial infrastructure from scratch. The focus is on studies that can quickly generate the kind of evidence needed to justify and properly design a larger, later phase clinical trial. This includes exploratory clinical trials of investigational agents such as drugs and biologics, as well as surgical approaches and medical devices. It also explicitly supports biomarker validation projects and proof of mechanism studies, meaning research aimed at showing that an intervention is engaging its intended biological target or pathway in people, even if the study is not yet powered to prove clinical benefit.
A central theme of the opportunity is alignment with the mission and priorities of the National Institute of Neurological Disorders and Stroke (NINDS). Applicants are expected to propose diseases and research questions that fit within the NINDS strategic plan and identified clinical research interests. In practical terms, that means the program is looking for trials that address important unmet needs in neurological disorders and that are plausibly positioned to move the field forward, either by de-risking a therapeutic strategy, establishing feasibility and operational parameters for a future definitive trial, or validating biomarkers that can improve trial design and interpretation.
What makes the X01 mechanism distinctive is that the main "award" is access to the NeuroNEXT infrastructure rather than a traditional pot of grant dollars for building trial operations independently. NeuroNEXT is a coordinated network built to run multicenter neurological clinical studies efficiently and consistently. Once an application is peer reviewed, NINDS does not simply fund every meritorious project; instead, it prioritizes and sequences which trials will receive access to the network resources. This reflects the reality that shared network capacity is finite, so projects are effectively queued based on scientific merit, feasibility, and programmatic priorities.
For selected projects, NeuroNEXT provides a structured set of supports through its coordinating centers and clinical sites. The NeuroNEXT Clinical Coordinating Center (CCC) works with the successful applicant to stand up the trial efficiently, which can include assistance with operational planning, site coordination, regulatory and start-up activities, and the practical details of launching a multicenter study. The NeuroNEXT Data Coordinating Center (DCC) provides statistical expertise and data management support, which typically includes input on study design and analysis planning, database and data capture systems, data quality oversight, and support for reliable, audit-ready trial data. In addition, the NeuroNEXT clinical sites contribute real-world execution capacity: they help with participant recruitment and retention, and they carry out the protocol on the ground in a standardized way across multiple locations. Taken together, these pieces are meant to reduce start-up time, improve consistency across sites, and increase the likelihood that an early phase study produces interpretable, decision-grade results.
From an applicant standpoint, the opportunity is broadly open to many organization types, reflecting NIH's typical inclusiveness for clinical research. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), state and local governments, U.S. territories or possessions, tribal governments and tribal organizations, school districts, special district governments, and public housing authorities/Indian housing authorities. The eligibility language also highlights categories such as historically underrepresented and mission-specific institutions (for example HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISIS-designated institutions), as well as faith-based or community-based organizations and eligible federal agencies. Notably, the announcement indicates that non-U.S. entities (foreign organizations) and regional organizations may also be eligible, which is relevant for studies needing international collaboration or specialized populations, though applicants would still need to fit the program goals and any NIH policy requirements.
Administratively, this is a discretionary grant opportunity under the NIH, listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost sharing or matching requirement. The FOA was posted on April 30, 2015, with an original and final closing date of November 12, 2017, and it was archived on December 13, 2017. While it is not currently open based on those dates, the summary remains useful as a guide to how NINDS structured NeuroNEXT access awards and what kinds of clinical studies the network was intended to enable.
In plain terms, the NeuroNEXT X01 opportunity was built for teams that have a strong clinical question and a credible investigational intervention or biomarker plan, but who would benefit from plugging into an existing multicenter trial engine. If the study fits NINDS priorities and earns a strong review, the payoff is a faster, more standardized path to generating the feasibility, mechanistic, or biomarker evidence needed before launching a larger confirmatory trial.
Frequently Asked Questions (FAQs): NeuroNEXT Infrastructure Resource Access (X01) - PAR 15-195
What is the NeuroNEXT Infrastructure Resource Access (X01) opportunity (PAR 15-195)?
The NeuroNEXT Infrastructure Resource Access (X01) opportunity is a National Institutes of Health (NIH) program designed to help investigators run early stage, exploratory clinical studies in neurology by providing access to the established NeuroNEXT national clinical trials network. Instead of requiring a team to build multicenter trial infrastructure from scratch, the X01 mechanism enables investigators to "plug into" existing network resources to launch and conduct a study more efficiently and consistently.
What is the main purpose of this X01 mechanism?
The core purpose is to generate early, decision-grade evidence that can justify and properly design a larger, later-phase clinical trial. The program emphasizes studies that can be executed relatively quickly and that reduce uncertainty (for example, by clarifying feasibility, operational parameters, or biological activity) before a definitive trial is attempted.
What types of studies are supported?
Based on the opportunity description, supported studies include early stage, exploratory clinical trials in neurology, such as:
- Exploratory clinical trials of investigational agents (including drugs and biologics)
- Studies of surgical approaches
- Studies of medical devices
- Biomarker validation projects
- Proof-of-mechanism studies (showing an intervention engages its intended biological target or pathway in people, even if not powered to prove clinical benefit)
Does the program support biomarker validation and proof-of-mechanism research?
Yes. The description explicitly states that biomarker validation projects and proof-of-mechanism studies are supported. This includes research aimed at demonstrating that an intervention is engaging its intended biological target or pathway in humans, even if the study is not designed or powered to demonstrate clinical benefit yet.
What is meant by "early stage" or "exploratory" clinical studies in this context?
In this program context, early stage and exploratory studies are those intended to quickly produce evidence needed to plan a future, larger trial. Examples include studies designed to establish feasibility, refine operations for a later multicenter trial, de-risk a therapeutic strategy, or validate biomarkers that can improve later trial design and interpretation.
How does alignment with NINDS priorities affect an application?
A central theme is alignment with the mission and priorities of the National Institute of Neurological Disorders and Stroke (NINDS). Applicants are expected to propose diseases and research questions that fit within the NINDS strategic plan and identified clinical research interests, focusing on important unmet needs in neurological disorders and questions that can plausibly move the field forward.
What kinds of impacts is NINDS looking for from supported projects?
The opportunity description indicates the program is looking for studies that can move the field forward by doing things like:
- De-risking a therapeutic strategy
- Establishing feasibility and operational parameters for a later definitive trial
- Validating biomarkers to improve trial design and interpretation
What makes the X01 mechanism different from a traditional grant?
The distinctive feature is that the primary "award" is access to the NeuroNEXT infrastructure rather than a traditional grant budget intended to build and run trial operations independently. In practical terms, the value comes from being able to use an established multicenter trial network and its coordinating resources.
Is access to the NeuroNEXT network guaranteed if an application receives a strong peer review?
No. After peer review, NINDS does not automatically provide network access to every meritorious project. The description states that NINDS prioritizes and sequences which trials receive access to the shared network resources, reflecting that network capacity is finite and projects may be queued based on scientific merit, feasibility, and programmatic priorities.
Why are projects prioritized and sequenced instead of all being supported at once?
The opportunity explains that NeuroNEXT is a shared national network with finite capacity. Because the network cannot run an unlimited number of studies simultaneously, NINDS must prioritize and sequence (queue) projects based on factors including scientific merit, feasibility, and alignment with program priorities.
What support does the NeuroNEXT Clinical Coordinating Center (CCC) provide?
For selected projects, the NeuroNEXT Clinical Coordinating Center (CCC) works with the successful applicant to stand up the trial efficiently. The description notes CCC support can include operational planning, site coordination, regulatory and start-up activities, and the practical details involved in launching a multicenter study.
What support does the NeuroNEXT Data Coordinating Center (DCC) provide?
For selected projects, the NeuroNEXT Data Coordinating Center (DCC) provides statistical expertise and data management support. The description indicates this typically includes input on study design and analysis planning, database and data capture systems, data quality oversight, and support for producing reliable, audit-ready trial data.
What role do NeuroNEXT clinical sites play in a supported project?
The NeuroNEXT clinical sites contribute execution capacity. According to the description, sites help with participant recruitment and retention and carry out the protocol in a standardized way across multiple locations, supporting consistent trial conduct in a multicenter setting.
How does using NeuroNEXT infrastructure benefit an early phase trial?
The description emphasizes that the combined supports (CCC, DCC, and clinical sites) are intended to reduce start-up time, improve consistency across sites, and increase the likelihood that an early phase study produces interpretable results suitable for making next-step decisions (for example, whether and how to proceed to a larger trial).
Who is eligible to apply?
The opportunity is broadly open to many organization types. Eligible applicants listed include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), state and local governments, U.S. territories or possessions, tribal governments and tribal organizations, school districts, special district governments, and public housing authorities/Indian housing authorities.
Are specific institution types (such as HBCUs or Hispanic-serving institutions) mentioned as eligible?
Yes. The eligibility language highlights historically underrepresented and mission-specific institutions, including examples such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISIS-designated institutions. It also mentions faith-based or community-based organizations and eligible federal agencies.
Are non-U.S. (foreign) organizations eligible?
Yes. The description notes that non-U.S. entities (foreign organizations) and regional organizations may also be eligible. This can matter for studies that need international collaboration or access to specialized populations, though applicants must still fit the program goals and any NIH policy requirements.
Is cost sharing or matching required?
No. The opportunity explicitly states there is no cost sharing or matching requirement.
What NIH program area and listing is associated with this opportunity?
Administratively, the opportunity is listed under CFDA 93.853, described as Extramural Research Programs in the Neurosciences and Neurological Disorders.
When was the funding opportunity posted, and is it still open?
The FOA was posted on April 30, 2015. The original and final closing date listed is November 12, 2017, and it was archived on December 13, 2017. Based on those dates, it is not currently open.
If it is archived, why is the summary still useful?
The description indicates that while the opportunity is not currently open, the summary remains useful as a guide to how NINDS structured NeuroNEXT access awards and the kinds of clinical studies the network was intended to enable.
What kinds of applicant teams is the program designed to help?
In plain terms, it is built for teams with a strong clinical question and a credible plan involving an investigational intervention or biomarker approach, who would benefit from using an existing multicenter trial engine rather than creating trial operations independently.
What is the expected outcome for a successful project using NeuroNEXT?
The described payoff is a faster, more standardized path to generating feasibility, mechanistic, or biomarker evidence needed before launching a larger confirmatory trial, assuming the study aligns with NINDS priorities and is selected to receive access to network resources.
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