Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 – Clinical Trials Required)
Can you apply?
This grant is for research institutions and universities seeking to renew existing NIH clinical trial cooperative agreements in neurology and neuroscience. Eligible applicants include domestic organizations (nonprofit institutions, universities, state and local governments) with active NINDS-supported U01 awards. Only institutions with demonstrated research capacity and prior funding success can apply.
This is a limited competition award, meaning only previously funded researchers or institutions can apply. Domestic research institutions, including those serving tribal entities, may be eligible. International collaborative research is permitted, but the primary applicant must be US-based.
The award supports clinical trials in neurological and neuroscience research areas. Projects must advance NINDS research priorities and demonstrate continuity with prior funded work. Renewal applications require evidence of substantial progress and impact.
This grant is for research institutions and universities seeking to renew existing NIH clinical trial cooperative agreements in neurology and neuroscience. Eligible applicants include domestic organizations (nonprofit institutions, universities, state and local governments) with active NINDS-supported U01 awards. Only institutions with demonstrated research capacity and prior funding success can apply.
This is a limited competition award, meaning only previously funded researchers or institutions can apply. Domestic research institutions, including those serving tribal entities, may be eligible. International collaborative research is permitted, but the primary applicant must be US-based.
The award supports clinical trials in neurological and neuroscience research areas. Projects must advance NINDS research priorities and demonstrate continuity with prior funded work. Renewal applications require evidence of substantial progress and impact.
Program description
This limited competition Notice of Funding Opportunity (NOFO) invites renewal applications of existing NINDS-supported clinical trial cooperative agreement awards (U01) requiring additional time and resources to complete the clinical trial.
Who can apply
Eligible applicants
Details
This grant is for research institutions and universities seeking to renew existing NIH clinical trial cooperative agreements in neurology and neuroscience. Eligible applicants include domestic organizations (nonprofit institutions, universities, state and local governments) with active NINDS-supported U01 awards. Only institutions with demonstrated research capacity and prior funding success can apply.
This is a limited competition award, meaning only previously funded researchers or institutions can apply. Domestic research institutions, including those serving tribal entities, may be eligible. International collaborative research is permitted, but the primary applicant must be US-based.
The award supports clinical trials in neurological and neuroscience research areas. Projects must advance NINDS research priorities and demonstrate continuity with prior funded work. Renewal applications require evidence of substantial progress and impact.
How to apply
Application links
Required documents
- SF-424 (Research and Related Activities)
- Project Narrative (Research Strategy)
- Detailed Budget and Budget Justification
- Biosketch (all key personnel)
- Prior NINDS Progress Report
- Data and Safety Monitoring Plan
- Human Subjects Protection documentation
- Institutional Commitment letters
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$82,511,281
-
$67,362,785
-
$62,646,087
-
$56,144,651
-
$45,268,737
-
$40,959,789
-
$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
Top States by Funding
- MA 6 awards $186.5M
- CA 4 awards $129.9M
- OH 4 awards $112.5M
- FL 3 awards $100.3M
- MN 2 awards $99.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this renewal award?
Only institutions with existing active NINDS-supported U01 awards can apply. This is limited competition, not open to new applicants.
What types of research are supported?
Clinical trials in neurology, neuroscience, and related neurological disorders. Studies must align with NINDS research priorities.
What is the timeline for the 2027 cycle?
Applications open October 28, 2024. The deadline is November 5, 2027. Plan for significant preparation time.
How competitive are U01 renewal awards?
Very competitive. Reviewers expect documented progress, publications, and strong enrollment/retention outcomes from prior work.
What funding amounts are typical?
Cooperative agreements vary widely based on research scope. Budget justification must be thorough and well-documented.
💡 Tips for applicants
- Start grant preparation 6-12 months before deadline. U01 renewals require extensive progress documentation and publication records.
- Emphasize continuity and impact. Clearly connect proposed work to prior NINDS-funded research and expected outcomes.
- Assemble a strong clinical trial team. Include biostatisticians, data managers, and experienced trial coordinators.
- Address recruitment and retention strategies upfront. Reviewers scrutinize enrollment feasibility and participant diversity.
- Have institutional support confirmed early. IRB protocols, compliance infrastructure, and senior leadership commitment are essential.
⚠️ Common mistakes
Underestimating complexity of clinical trial budgeting and timelines. Weak documentation of prior progress or impact from funded research. Insufficient detail on diversity recruitment and retention strategies for trial participants.
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