Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
Can you apply?
This grant is for research organizations that propose clinical validation studies of candidate biomarkers for neurological or neuromuscular disorders. Eligible applicants include research institutions, academic medical centers, and nonprofit research organizations with appropriate NIH regulatory infrastructure. The work must involve human subjects research and comply with IRB requirements. Research can be conducted domestically or internationally, but applicants must have U.S. institutional affiliations. Projects range from biomarker discovery validation through early clinical testing phases.
Applicants must demonstrate institutional capacity for clinical research. This includes access to patient populations, clinical facilities, and regulatory compliance experience. The project should propose rigorous biomarker validation protocols. Small business innovation is possible through SBIR/STTR mechanisms if applicable. Foreign institutions may participate as collaborators but cannot be primary applicants.
This grant is for research organizations that propose clinical validation studies of candidate biomarkers for neurological or neuromuscular disorders. Eligible applicants include research institutions, academic medical centers, and nonprofit research organizations with appropriate NIH regulatory infrastructure. The work must involve human subjects research and comply with IRB requirements. Research can be conducted domestically or internationally, but applicants must have U.S. institutional affiliations. Projects range from biomarker discovery validation through early clinical testing phases.
Applicants must demonstrate institutional capacity for clinical research. This includes access to patient populations, clinical facilities, and regulatory compliance experience. The project should propose rigorous biomarker validation protocols. Small business innovation is possible through SBIR/STTR mechanisms if applicable. Foreign institutions may participate as collaborators but cannot be primary applicants.
Program description
The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research organizations that propose clinical validation studies of candidate biomarkers for neurological or neuromuscular disorders. Eligible applicants include research institutions, academic medical centers, and nonprofit research organizations with appropriate NIH regulatory infrastructure. The work must involve human subjects research and comply with IRB requirements. Research can be conducted domestically or internationally, but applicants must have U.S. institutional affiliations. Projects range from biomarker discovery validation through early clinical testing phases.
Applicants must demonstrate institutional capacity for clinical research. This includes access to patient populations, clinical facilities, and regulatory compliance experience. The project should propose rigorous biomarker validation protocols. Small business innovation is possible through SBIR/STTR mechanisms if applicable. Foreign institutions may participate as collaborators but cannot be primary applicants.
How to apply
Application links
Required documents
- SF-424 (R&R) Application Form
- Project Narrative (Research Plan)
- Biographical Sketches (4-5 pages each, key personnel)
- Budget Justification
- NIH Form 398 or eRA Commons Appendix
- Institutional Certifications and Assurances
- Vertebrate Animal Protocol (if applicable)
- Human Subjects Research Documentation
- Letters of Support (clinical sites, collaborators)
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 grant?
Research institutions, universities, hospitals, and nonprofit organizations with clinical research capacity. For-profit companies may apply under SBIR/STTR programs.
What is the application deadline?
The deadline is June 22, 2026. Applications open October 2, 2024. Check NIH eRA Commons for exact submission windows.
What activities does this grant support?
Clinical validation studies of neurological or neuromuscular biomarkers. Research may include observational studies, clinical trials, and biospecimen analysis.
How competitive is this grant?
U01 grants are highly competitive. Success rates typically range from 15-25%. Strong preliminary data and experienced research teams are essential.
What funding amounts are typical?
Budget varies widely. Check NIH funding information for this CFDA number. Multi-year projects commonly receive $200,000-$500,000 annually.
💡 Tips for applicants
- Establish preliminary biomarker validity before applying. Demonstrate proof-of-concept with existing data.
- Partner with neurologists or neuromuscular specialists early. Clinical expertise strengthens the application significantly.
- Plan realistic timelines for patient recruitment and enrollment. Show you understand disease-specific challenges.
- Address regulatory pathways clearly. Explain how results will inform clinical decision-making or drug development.
- Include a strong statistical analysis plan. Specify primary biomarker endpoints and validation criteria in advance.
⚠️ Common mistakes
Weak preliminary data or unclear biomarker rationale. Applicants often propose validation without sufficient evidence of potential clinical utility. Unrealistic recruitment timelines for rare disease cohorts. Many proposals underestimate time needed to enroll patients with specific neurological conditions. Inadequate attention to regulatory compliance. Missing details about IRB oversight and informed consent procedures.
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