Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
ID: 356621Type: 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/356621

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders, focusing on establishing their clinical sensitivity and specificity in accordance with FDA guidelines. The program is particularly significant as it seeks to enhance public health outcomes by facilitating the implementation of validated biomarkers in clinical settings, thereby addressing critical healthcare needs in these areas. Interested applicants should note that the application period opens on January 21, 2025, and closes on June 22, 2026. For further inquiries, applicants 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-25-055.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-055.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is offering a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." The purpose of this funding opportunity is to support the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders, aiming to establish their clinical sensitivity and specificity according to FDA guidelines. The funding is available for applications that include a well-defined context of use for one or two biomarker types, demonstrating prior preliminary testing and analytical validation. Key dates include an application open date of January 21, 2025, and an expiration date of June 23, 2026. The application requires a Plan for Enhancing Diverse Perspectives (PEDP) and detailed justification of the study design, statistical analysis, and collaborative partnerships. The innovative research is aimed at advancing public health by facilitating appropriate biomarker implementation in clinical settings, reflecting NIH’s goal in enhancing healthcare outcomes for neurological and neuromuscular disorders. Applications that do not adhere to specific guidelines will be eliminated from the review process, ensuring a focus on rigor and scientific merit.
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