Opportunity Information: Apply for PAR 16 155
Apply for PAR 16 155
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NeuroNEXT Clinical Trials (U01)" 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 Mar 28, 2016 and posted on Mar 28, 2016.
- Applicants must submit their applications by Aug 03, 2017. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NeuroNEXT Clinical Trials (U01) opportunity (Funding Opportunity Number PAR-16-155) is a National Institutes of Health program, administered through HHS/NIH (listed as HHS-NIH11) and aligned with the National Institute of Neurological Disorders and Stroke (NINDS). It supports exploratory clinical trials that test investigational agents and interventions in neurology, including drugs, biologics, surgical approaches, or medical devices. The central goal is to generate early human evidence that helps decide whether a larger, later-stage trial is warranted and how it should be designed. This can include studies that produce the practical data needed to plan a future definitive trial, biomarker validation studies that establish whether a biomarker is reliable and clinically meaningful, and proof-of-mechanism trials that show whether an intervention is engaging the intended biological pathway in humans.
A key requirement is that the disease area and scientific rationale fit within NINDS priorities. Applicants are expected to select conditions that map to the NINDS strategic plan and current clinical research interests, as referenced on the NINDS funding areas webpage. In other words, the program is not a general-purpose clinical trial grant for any medical condition; it is designed to advance neurological clinical research that NINDS considers high priority, with an emphasis on studies that de-risk or accelerate the next stage of development.
This funding opportunity uses a cooperative agreement mechanism (U01), which generally indicates substantial NIH involvement in the conduct of the project compared with a standard research project grant. In practice, that cooperative structure is reflected in the major program feature of this FOA: successful applicants receive access to the NeuroNEXT network infrastructure rather than operating entirely on their own. NeuroNEXT is a coordinated clinical trials network intended to make multicenter neurology trials faster and more consistent by providing established operational capabilities, experienced sites, and centralized coordination.
Once applications are peer reviewed, NINDS does not automatically support every meritorious trial through NeuroNEXT. Instead, NINDS will prioritize and sequence the proposed trials that are granted access to the network, meaning there is an additional programmatic step where NINDS determines which reviewed applications will move forward within the NeuroNEXT system and in what order. For applications that are selected, the NeuroNEXT Clinical Coordinating Center (CCC) partners with the awardee to implement the study efficiently, helping to operationalize the protocol across sites and supporting trial start-up and execution. The NeuroNEXT Data Coordinating Center (DCC) provides statistical and data management support, which typically includes planning and oversight of data capture, quality control processes, and statistical input needed for analysis and reporting. NeuroNEXT clinical sites then contribute directly to recruitment and retention and carry out on-site implementation of the protocol, which is often one of the biggest practical barriers for early-stage multicenter trials.
Eligibility is broad and includes many types of organizations: state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities as described in the FOA’s eligibility clarifications. Importantly, applicants do not need to already be part of the NeuroNEXT network to apply, which lowers the barrier for external investigators, academic groups, and industry partners to propose trials that can benefit from the network’s established infrastructure.
From an administrative standpoint, the opportunity is categorized as discretionary funding, with a health-related activity category and CFDA number 93.853. The FOA was posted and created on March 28, 2016, and the listed closing date for applications was August 3, 2017. The source data provided does not specify an award ceiling or the expected number of awards, so interested applicants would typically need to consult the full FOA text or associated NIH documentation for budget expectations, project period norms, and any limits or guidance on allowable costs.
Overall, this FOA is best understood as a pathway for investigators to run well-supported, early clinical studies in neurological disorders, where the immediate deliverable is high-quality evidence to justify, design, and power subsequent trials, validate biomarkers, or demonstrate mechanism in humans, while leveraging NeuroNEXT’s coordinating centers and clinical site network to improve feasibility, consistency, and speed.
NeuroNEXT Clinical Trials (U01) (PAR-16-155) - FAQs
What is the NeuroNEXT Clinical Trials (U01) funding opportunity?
The NeuroNEXT Clinical Trials (U01) opportunity (Funding Opportunity Number PAR-16-155) is an NIH program administered through HHS/NIH and aligned with the National Institute of Neurological Disorders and Stroke (NINDS). It supports exploratory clinical trials in neurology and is designed to help generate early human evidence that informs whether a larger, later-stage trial should be done and how that future trial should be designed.
Which federal agency and NIH institute are associated with this opportunity?
The opportunity is administered through the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), and is aligned with NINDS (the National Institute of Neurological Disorders and Stroke).
What kind of research does this FOA support?
This FOA supports exploratory clinical trials that test investigational agents and interventions in neurology. Examples include trials involving drugs, biologics, surgical approaches, or medical devices. The focus is on generating practical, early-stage evidence in humans that reduces uncertainty and supports next-step decision-making.
What is the main goal of the trials supported by this program?
The central goal is to generate early human evidence that helps decide whether a larger, later-stage trial is warranted and how it should be designed. The program emphasizes studies that de-risk or accelerate the next stage of clinical development in neurological disorders.
What types of study objectives are specifically mentioned as a fit for this FOA?
The description highlights several examples of objectives that can fit this FOA, including:
- Studies that produce practical data needed to plan a future definitive trial
- Biomarker validation studies aimed at establishing whether a biomarker is reliable and clinically meaningful
- Proof-of-mechanism trials that assess whether an intervention engages the intended biological pathway in humans
Is this a general clinical trial grant for any disease area?
No. A key requirement is that the disease area and scientific rationale fit within NINDS priorities. The program is intended to advance neurological clinical research that NINDS considers high priority, rather than serving as a general-purpose clinical trial mechanism for any medical condition.
How do applicants determine whether their condition aligns with NINDS priorities?
Applicants are expected to select conditions that map to the NINDS strategic plan and current clinical research interests, as referenced on the NINDS funding areas webpage. The expectation is that both the disease area and the scientific rationale align with what NINDS considers a priority.
What does it mean that this award uses a cooperative agreement mechanism (U01)?
A cooperative agreement (U01) generally indicates substantial NIH involvement in the conduct of the project compared with a standard research project grant. In this FOA, that cooperative structure is reflected by the use of the NeuroNEXT network infrastructure and coordination rather than the awardee operating entirely independently.
What is NeuroNEXT and why is it important for this FOA?
NeuroNEXT is a coordinated clinical trials network intended to make multicenter neurology trials faster and more consistent. It provides established operational capabilities, experienced sites, and centralized coordination. A major feature of this FOA is that successful applicants receive access to this network infrastructure.
Do applicants need to already be part of the NeuroNEXT network to apply?
No. Applicants do not need to already be part of the NeuroNEXT network to apply. This is specifically noted as lowering the barrier for external investigators, academic groups, and industry partners to propose trials that could benefit from NeuroNEXT infrastructure.
What happens after peer review?
After applications are peer reviewed, NINDS does not automatically support every meritorious trial through NeuroNEXT. Instead, NINDS will prioritize and sequence the proposed trials that are granted access to the network. This means there is an additional programmatic step where NINDS determines which reviewed applications will move forward within the NeuroNEXT system and in what order.
Does a strong peer review outcome guarantee access to NeuroNEXT?
No. The information provided states that NINDS will prioritize and sequence trials for NeuroNEXT access after peer review, so support through the NeuroNEXT system is not automatic for every meritorious application.
What role does the NeuroNEXT Clinical Coordinating Center (CCC) play?
For applications selected to move forward, the NeuroNEXT Clinical Coordinating Center (CCC) partners with the awardee to implement the study efficiently. This includes helping operationalize the protocol across sites and supporting trial start-up and execution.
What role does the NeuroNEXT Data Coordinating Center (DCC) play?
The NeuroNEXT Data Coordinating Center (DCC) provides statistical and data management support. This typically includes planning and oversight of data capture, quality control processes, and statistical input needed for analysis and reporting.
What role do NeuroNEXT clinical sites play in a supported trial?
NeuroNEXT clinical sites contribute directly to recruitment and retention and carry out on-site implementation of the protocol. This site-level execution is highlighted as a major practical barrier for early-stage multicenter trials that the network helps address.
What kinds of organizations are eligible to apply?
Eligibility is broad and includes many types of organizations, including:
- State, county, and local governments
- Special district governments
- Independent school districts
- Public and state-controlled universities
- Private institutions of higher education
- Federally recognized tribal governments and other tribal organizations
- Public and Indian housing authorities
- Nonprofit organizations (with or without 501(c)(3) status)
- For-profit organizations (other than small businesses) and small businesses
- Other entities as described in the FOA's eligibility clarifications
Is this opportunity tied to a specific funding category or program classification?
Yes. The opportunity is categorized as discretionary funding, with a health-related activity category and CFDA number 93.853.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is PAR-16-155.
When was the FOA posted and what was the listed closing date?
The FOA was posted and created on March 28, 2016. The listed closing date for applications was August 3, 2017.
Does the provided information include the award ceiling or expected number of awards?
No. The source information provided does not specify an award ceiling or the expected number of awards. To find budget expectations, project period norms, and any limits or guidance on allowable costs, applicants would typically consult the full FOA text or associated NIH documentation.
What is the practical value of this program for early-stage multicenter trials?
This FOA is presented as a pathway to run well-supported early clinical studies in neurological disorders, where the immediate deliverable is high-quality evidence (to justify, design, and power subsequent trials, validate biomarkers, or demonstrate mechanism in humans) while leveraging NeuroNEXT coordination and clinical sites to improve feasibility, consistency, and speed.
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