Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
Validate biomarker for neurological disorders in clinical population to establish predictive values, assuming biomarker & detection method exists.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health (NIH)
Due Dates: November 17, 2025 (full application deadline)
Funding Amounts: Award size not specified; budgets must be reasonable and appropriate for the proposed project. No cost-sharing required.
Summary: Supports rigorous clinical validation of candidate biomarkers for neurological or neuromuscular disorders, aiming to establish predictive values in alignment with FDA guidelines.
Key Information: Applicants must have already identified and analytically validated a candidate biomarker and detection method.
Description
This funding opportunity enables researchers to conduct clinical validation of strong candidate biomarkers for neurological or neuromuscular diseases and conditions. The goal is to rigorously validate biomarker measurements within the relevant clinical population to establish their positive and negative predictive values, consistent with FDA guidelines. The program is intended for projects where a candidate biomarker and detection method have already been identified and analytically validated, and the research or clinical need and potential context of use have been defined.
