Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional) - PAR-25-055
Funder
National Institutes of Health
LOI Deadline
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LOI Required
Recommended, but not required
Application Deadline
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Maximum Project Duration
5 years
Research Focus Areas
Neurobiology/Neuroscience
Molecular and Cellular
Biomarkers
Research Methods
Neural Networks
Randomized Control Trials (RCT)
Description
The purpose of this notice of funding opportunity (NOFO) is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.