Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 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: Unspecified amount

Funding uses: Research

Location of project: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico, Virgin Islands Show all

Location of residency: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico, Virgin Islands Show all

Overview:

NOTE: All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed dates by 5:00 PM local time of applicant organization:  February 22, 2023, and June 22, 2023

All AIDS Application Due Date allowed for this funding opportunity announcement are due on the listed dates by 5:00 PM local time of applicant organization:  May 7, 2023, September 7, 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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