Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
ID: 351913Type: 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/351913

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-096.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)" aimed at supporting the clinical validation of candidate biomarkers for neurological diseases. This initiative seeks proposals from small businesses to demonstrate the clinical effectiveness of identified biomarkers, ensuring they meet FDA guidelines for validation, including establishing their clinical sensitivity and specificity. The funding opportunity allows for both Phase I and Phase II applications, with budget limits of up to $700,000 and $1,500,000, respectively, over a period of two to three years. Interested applicants should note that the application submission begins on February 22, 2024, and for further inquiries, they can contact NIH Grants Information at grantsinfo@nih.gov. More details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-24-096.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-096-Full-Announcement.html
    PAR-24-096.html
    The Department of Health and Human Services, via the National Institutes of Health (NIH), has issued a funding opportunity aimed at validating candidate biomarkers for neurological and neuromuscular disorders. This initiative, designated as PAR-24-096, encourages small businesses to propose studies that demonstrate the clinical effectiveness of biomarkers within defined contexts of use. The primary goal is to establish the clinical sensitivity and specificity of these biomarkers in alignment with FDA guidelines, ensuring they meet rigorous validation standards. Applicants must provide a comprehensive plan for enhancing diverse perspectives within their research teams and demonstrate the feasibility of integrating the biomarkers into clinical practice or trials. The funding supports both Phase I and Phase II applications with budget limits of up to $700,000 and $1,500,000, respectively, across a period of two to three years. Key dates for application submission begin on February 22, 2024, with a series of review cycles extending into 2027. This funding opportunity underscores the NIH's commitment to fostering diversity in scientific research and advancing public health through biomarker innovation.
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