Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
National Institutes of Health (NIH)
Total funding amount is not specified.
Maximum project period is 5 years.
To enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders.
Researchers in the field of neurology and neuromuscular disorders.
Patients with neurological and neuromuscular conditions.
This is a reissue of PAR-24-097.
Funded by the National Institutes of Health (NIH).
Type: Cooperative Agreement.
Addresses the critical need for advancing biomarker validation in neurological disorders.
Recurring grant opportunity.
Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Small Businesses
Local Governments
State Governments
County Governments
City or Township Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government Agencies
U.S. Territory or Possession
Other organizations such as Independent School Districts, Public Housing Authorities, Faith-based Organizations, and Regional Organizations.
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Organizations must be based in the U.S. Non-domestic (non-U.S.) entities are not eligible to apply.
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Clinical validation of biomarkers for neurological and neuromuscular disorders.
Healthcare, specifically neurology and neuromuscular disorders.
Patients with neurological and neuromuscular disorders, researchers.
Must be based in the U.S.
Applications that do not include a context of use statement or milestones will be withdrawn.
Establish clinical sensitivity and specificity of biomarkers.
Must align with NIH's mission to improve public health.
Enhance therapeutic development and clinical decision-making.
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Multidisciplinary collaboration among scientific investigators, clinical scientists, and regulatory experts is encouraged.
Must include a clear and well-justified study design and statistical design.
Must adhere to FDA guidance standards.
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An Intellectual Property plan is encouraged.
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Must comply with NIH policies.
Application budgets are not limited but must reflect the actual needs of the proposed project.
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Earliest submission date is January 21, 2025.
Application due dates vary, with the last one being June 22, 2026.
Maximum project period is 5 years.
Must include a clear and feasible timeline with quantitative annual milestones.
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Annual quantitative milestones are required.
Milestones will be used to monitor project progress.
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Must comply with NIH policies.
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Applications must include annual milestones.
Applications must be submitted electronically through Grants.gov.
Applications will be evaluated for scientific and technical merit.
Applications will undergo a peer review process.
Priority may be placed on applications that fill a critical program gap.
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Applications must be submitted through Grants.gov.
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Resubmissions will be evaluated based on changes made.
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