Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
ID: 356624Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/356624

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-050.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the rigorous analytical validation of methods used to measure biomarkers for neurological and neuromuscular disorders, which are critical for clinical trials and practice. Applicants are required to demonstrate the unmet need for the biomarker(s) and measurement methods, detailing activities such as optimizing accuracy, precision, and establishing quality control procedures across multiple sites. The submission portal opens on January 21, 2025, with applications due by June 22, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-050.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-050.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), has issued a funding opportunity to support the analytical validation of biomarkers for neurological and neuromuscular disorders. The funding, titled "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)," aims to rigorously assess measurement methods for biomarkers that could be used in clinical trials or practice. Applicants are expected to demonstrate the clinical and research needs for the biomarker(s) and validation methods, ensuring accuracy and reliability. Key activities include establishing testing sensitivity, specificity, and precision, especially across multiple testing sites. Applications must detail milestones, convey collaborative efforts among diverse scientific and clinical teams, and include a 'Plan for Enhancing Diverse Perspectives' to foster inclusivity. The submission portal is open from January 21, 2025, with awards contingent upon available funding and selected applications being subjected to peer review. The NIH emphasizes that proposals need to address an unmet medical need, display a substantial biological rationale, and clearly outline plans for evaluating the performance and clinical utility of the proposed biomarkers.
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