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

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate 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. This funding mechanism uses the U01 cooperative agreement instrument, which allows for substantial involvement from NIH staff in the conduct of the research.