Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
Clinical trial to validate a biomarker for neurological disorders, ensuring accuracy in patient populations, aligned with FDA standards.
Funder: National Institutes of Health
Due Dates: May 21, 2025 (LOI) | June 20, 2025 (Full) | Jan 21, 2026 (LOI) | Feb 20, 2026 (Full) | May 23, 2026 (LOI) | June 22, 2026 (Full)
Funding Amounts: No budget cap; up to 5 years per award; budgets must reflect actual project needs.
Summary: Supports rigorous clinical validation of candidate biomarkers for neurological or neuromuscular disorders, aligned with FDA standards.
Key Information: Candidate biomarker and detection method must already be identified and analytically validated; annual milestones required.
Description
This opportunity from the National Institutes of Health (NIH), led by the National Institute of Neurological Disorders and Stroke (NINDS), funds clinical validation studies of strong candidate biomarkers for neurological and neuromuscular disorders. The goal is to rigorously validate biomarker measurements in relevant clinical populations, establishing their predictive value and clinical utility in line with FDA guidelines. The program is intended for projects where a biomarker and its detection method have already been identified and analytically validated, and where the clinical or research need and context of use are well defined.
The funding mechanism is a U01 cooperative agreement, which includes substantial NIH programmatic involvement and milestone-driven project management.
