Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)

This is a grant proposal for the clinical examination of potential biomarkers for neurological or neuromuscular disorders. The funding opportunity, titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders" (reissued as PAR-21-058), does not require a clinical trial and covers neurological diseases and conditions. The aim of the programme is to further validate promising biomarkers within specific clinical populations, and it adheres to FDA guidelines when determining the predictive values of potential biomarkers.

The programme proposal assumes several things have already been accomplished: firstly, a potential biomarker has been identified; secondly, technology capable of detecting this biomarker has been developed and validated analytically; finally, the research and clinical needs, plus the prospective context of use for the biomarker, have been defined. In sum, the focus of this programme is to rigorously test and validate biomarker measurements within their relevant clinical environments.