Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

Predicted deadline: The deadline for this grant has passed

Grant amount: US $700,000 - US $1,500,000

Funding uses: Research

Location of project: United States

Location of residency: United States

Overview:

NOTE: This grant has a  Notice of Early Termination of PAR-21-059, and is ending early on August 9, 2023.

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

• a candidate biomarker has already been identified,
• detection method technology has already been developed and analytically validated, and 
• the research and/or clinical need and potential context of use has been identified.

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