Opportunity Information: Apply for PAR 18 420
The NINDS Exploratory Clinical Trials funding opportunity (PAR-18-420) is a National Institutes of Health (NIH) grant mechanism designed to support investigator-initiated, early-stage clinical trials in neurology and related areas covered by the National Institute of Neurological Disorders and Stroke (NINDS). It uses the U01 cooperative agreement format, which generally means the project is still led by the awardee, but NIH/NINDS typically expects a more active partnership than a standard research grant, especially around planning, oversight, and milestone-driven execution. A central requirement is that applications must include a clinical trial, and the proposed study must directly align with the NINDS mission and research priorities.
The program is aimed specifically at exploratory clinical trials, meaning studies that are intended to answer important preliminary questions before a larger, definitive efficacy trial is justified. These trials often focus on feasibility, safety, dosing, proof-of-concept signals, target engagement, preliminary efficacy, biomarker behavior, or optimizing intervention delivery and trial procedures. The opportunity is broad in terms of what kinds of interventions can be tested, as long as the research question fits within NINDS interests. Applicants may propose trials evaluating drugs, biologics, and medical devices, as well as surgical approaches, behavioral interventions, and rehabilitation therapies. In practical terms, this allows a wide range of neurology-focused clinical experimentation, from early human testing of a new device concept to pragmatic testing of a rehabilitation protocol, provided the work remains within NINDS scientific scope.
Eligibility is expansive and includes many types of institutions and organizations. Standard eligible applicants listed include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights 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, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It further notes eligibility for certain nontraditional or special categories including faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities, which is notable for investigators who may be planning multinational studies or leveraging specialized overseas patient populations or research infrastructure.
From an administrative standpoint, the opportunity is categorized as a discretionary grant in the health funding activity area and is associated with CFDA number 93.853 (NINDS). The funding instrument type is a grant using the U01 mechanism, and because it is explicitly labeled “Clinical Trials Required,” the application must be structured around a real interventional clinical trial rather than observational research only. The public source data provided lists an original closing date of 2021-05-06 and a creation date of 2017-11-29; applicants considering a similar submission today would typically confirm whether the FOA is still active or whether a reissued or updated NINDS clinical trial announcement has replaced it.
Overall, the opportunity is meant to help researchers move promising neurological interventions and therapeutic strategies into early clinical testing, generate high-value data needed to justify larger trials, and do so in areas that match NINDS priorities. The breadth of eligible applicants and intervention types suggests NINDS was aiming to attract a wide pool of investigators and partners, including academic, nonprofit, community-based, tribal, government, and industry participants, so long as the proposed exploratory trial addresses a meaningful NINDS-relevant clinical question.Apply for PAR 18 420
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials (U01 - Clinical Trials Required)" 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 2017-11-29.
- Applicants must submit their applications by 2021-05-06. (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.
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Frequently Asked Questions (FAQs): NINDS Exploratory Clinical Trials (PAR-18-420)
What is the NINDS Exploratory Clinical Trials funding opportunity (PAR-18-420)?
PAR-18-420 is an NIH funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) designed to support investigator-initiated, early-stage (exploratory) clinical trials in neurology and related areas within the NINDS mission.
What NIH grant mechanism does this opportunity use?
This opportunity uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement generally mean for how the project is run?
Under a U01, the project is still led by the awardee, but NIH/NINDS generally expects a more active partnership than a standard research grant. This often includes involvement in planning, oversight, and milestone-driven execution.
Are clinical trials required under this funding opportunity?
Yes. The opportunity is explicitly designated as "Clinical Trials Required," so the application must include an interventional clinical trial rather than observational research only.
What kind of clinical trial is this program intended to support?
The program is aimed at exploratory clinical trials. These are early-stage studies intended to answer important preliminary questions before a larger, definitive efficacy trial is justified.
What are examples of study aims that fit an exploratory clinical trial?
Examples include trials focused on feasibility, safety, dosing, proof-of-concept signals, target engagement, preliminary efficacy, biomarker behavior, and optimizing intervention delivery and trial procedures.
Does the proposed trial need to align with NINDS priorities?
Yes. A central requirement is that the clinical trial must directly align with the NINDS mission and research priorities.
What intervention types can be tested under this opportunity?
The opportunity is broad, as long as the research question fits within NINDS interests. Trials may evaluate drugs, biologics, and medical devices, as well as surgical approaches, behavioral interventions, and rehabilitation therapies.
Can a medical device clinical trial be supported?
Yes. Medical devices are specifically mentioned as an example of intervention types that may be evaluated, provided the trial remains within NINDS scientific scope.
Can surgical approaches be tested?
Yes. Surgical approaches are listed among the intervention types that may be evaluated if the topic fits NINDS interests.
Are behavioral interventions and rehabilitation therapies eligible for support?
Yes. Behavioral interventions and rehabilitation therapies are explicitly included as allowable intervention categories, as long as the clinical question aligns with NINDS priorities.
Is this funding intended for large, definitive efficacy trials?
No. It is intended to generate early, high-value data needed to justify larger trials, not to serve as the definitive efficacy study itself.
Who is eligible to apply?
Eligibility is expansive and includes many types of institutions and organizations, spanning government entities, educational institutions, nonprofits, for-profits, and small businesses, as well as certain additional categories highlighted in the opportunity.
What government entities are eligible applicants?
Eligible government applicants include state, county, city, township, and special district governments.
Are independent school districts eligible to apply?
Yes. Independent school districts are listed as eligible applicants.
Are colleges and universities eligible to apply?
Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments are eligible. The opportunity also lists Native American tribal organizations that are not federally recognized governments as eligible.
Are nonprofits eligible to apply?
Yes. Nonprofits with or without 501(c)(3) status (other than higher education institutions) are included among eligible applicants.
Can for-profit organizations apply?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible as a separate category.
Are minority-serving institutions specifically highlighted as eligible?
Yes. The opportunity highlights 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, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Are faith-based or community-based organizations eligible to apply?
Yes. The opportunity notes eligibility for certain nontraditional or special categories, including faith-based or community-based organizations.
Are federal agencies eligible applicants?
Yes. The opportunity notes eligibility for eligible federal agencies.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among the eligible applicant categories noted.
Can non-U.S. (foreign) entities apply?
Yes. The opportunity notes that non-U.S. (foreign) entities are eligible, which may be relevant to multinational studies or projects leveraging overseas patient populations or research infrastructure.
What is the funding activity area for this opportunity?
The opportunity is categorized as a discretionary grant in the health funding activity area.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.853 (NINDS).
What is the original closing date listed for PAR-18-420?
The public source data provided lists an original closing date of 2021-05-06.
What is the creation date listed for this opportunity?
The public source data provided lists a creation date of 2017-11-29.
If someone is considering applying now, what should they verify about the announcement?
Because the listed closing date is in 2021, applicants considering a similar submission today would typically confirm whether PAR-18-420 is still active or whether a reissued or updated NINDS clinical trial announcement has replaced it.
What is the overall purpose of this opportunity?
The overall purpose is to help researchers move promising neurological interventions and therapeutic strategies into early clinical testing, generate high-value data needed to justify larger trials, and do so in areas that match NINDS priorities.
What types of organizations does NINDS appear to be trying to attract through this FOA?
Based on the breadth of eligible applicants and intervention types, NINDS appears to be aiming to attract a wide pool of investigators and partners, including academic, nonprofit, community-based, tribal, government, and industry participants, as long as the proposed exploratory trial addresses an NINDS-relevant clinical question.
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