NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-27-065
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- State Governments
- Public or Indian Housing Auth.
- For Profit Organizations
- Tribal Organizations (Not Federally Recognized)
- Other
- 501(c)(3) Nonprofits
- Tribal Governments (Federally Recognized)
- Higher Education Inst. (Private)
- County Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- City/Township Governments
- Special District Governments
- Small Businesses
- Independent School Districts
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Neurological Disorders and Stroke (NINDS) is soliciting applications for investigator-initiated efficacy and exploratory clinical trials addressing neurological disorders, with applications due on a rolling basis through March 9, 2029, using the UG3/UH3 phased cooperative agreement mechanism.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal governments and organizations, housing authorities, school districts, and special district governments. Foreign organizations and non-domestic components of U.S. organizations are eligible; however, foreign subawards and subcontracts are not permitted under this NOFO.
Trials may evaluate small molecules, biologics, devices, and surgical, behavioral, diet-based, or rehabilitation therapies. Studies addressing neurological diseases across the lifespan are encouraged. The program accepts both early-phase exploratory trials and later-phase confirmatory Phase 3 or comparative effectiveness trials. The UG3 phase supports trial start-up and feasibility activities over up to 2 years, while the UH3 phase supports full implementation over up to 6 years, with a maximum combined project period of 7 years. Budget is not limited but must reflect actual project needs.
Applications must include detailed milestones, statistical analysis plans, data and safety monitoring plans, and a data management and sharing plan. Review emphasizes scientific significance, trial design rigor and feasibility, investigator expertise, and human subject protections. NINDS provides substantial programmatic involvement including regulatory oversight, steering committee participation, and close monitoring of enrollment milestones. Continuation to UH3 is contingent upon meeting agreed-upon UG3 milestones. Applicants investigating common neurological disorders are encouraged to consider NINDS-supported clinical trial networks (StrokeNet, NeuroNEXT, and SIREN); device study developers should consult NINDS program staff early in development.
Assistance Listing: 93.853.
Synopsis
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). These trials must address questions within the mission and research interests of the NINDS and may include studies of small molecules, biologics, devices as well as surgical, behavioral, diet-based, or rehabilitation therapies. Studies addressing neurological diseases and care across the lifespan are highly encouraged. This notice invites both early- and middle-phase exploratory clinical trials as well as later phase confirmatory Phase 3 or comparative effectiveness clinical trials.
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Files
| File | Type | Posted |
|---|---|---|
| PKG00294087.pdf | ||
| PAR-27-065-Full-Announcement.html | HTML file |
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