Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial Optional)
ID: 349885Type: 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/349885

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-23-258.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) titled "Analytical and Clinical Validation of Biomarkers for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD)," aimed at accelerating the development of effective biomarkers for these conditions. This funding opportunity, categorized under U01 Research Project Cooperative Agreements, seeks applications focused on the analytical and clinical validation of candidate biomarkers, adhering to standards comparable to the FDA's Biomarker Qualification Program. The initiative is particularly significant for enhancing patient care and clinical research, especially in underrepresented populations, by promoting studies that characterize biomarkers relevant to therapeutic efficacy and clinical decision-making. Interested applicants should note that the submission period opens on October 3, 2023, and closes on March 5, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at NIH Grants.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-23-258-Full-Announcement.html
    PAR-23-258.html
    The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) titled "Analytical and Clinical Validation of Biomarkers for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD)", aimed at accelerating the development of effective biomarkers. This funding opportunity, under the U01 Research Project Cooperative Agreements, seeks applications for the validation of candidate biomarkers with standards comparable to the FDA's Biomarker Qualification Program. Key dates for application include the submission opening on October 3, 2023, and the expiration date on March 6, 2026. The primary objective of the NOFO is to address gaps in AD/ADRD biomarker validation, promoting studies that characterize biomarkers with relevance to patient care and clinical research, especially in underrepresented populations. Successful projects may involve examining predictive, diagnostic, or monitoring biomarkers to enhance therapeutic efficacy and clinical decision-making. NIH emphasizes rigorous validation processes, requiring detailed methodologies, anticipated outcomes, and adherence to ethical research standards. Potential applicants must complete necessary registrations and submissions through appropriate channels, highlighting robust project plans, research strategies, and the significance of the proposed work to public health outcomes in the context of AD and ADRD.
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