Clinical and Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders

Cooperative agreements to USA, Canada, and International government agencies, IHEs, nonprofit and for-profit organizations, and small businesses for research related to neuromuscular and neurological conditions and disorders. Required registrations may take 6 weeks or more to complete.
PAR-21-056 and PAR-21-057:Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders:The purpose of these Program Announcements (PAR) is to enable analytical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of these PARs is to enable the rigorous validation of analytical methods for biomarker measurements, which should include evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. These PARs assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.Applicants with a detection method that has already been analytically validated for its intended Context of Use may apply directly to the companion PAR, Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 – Clinical Trial Optional)” which addresses retrospective and/or prospective clinical validation of candidate biomarkers for use in clinical trials and/or clinical practice.Research Objectives:Applications to these PARs must propose to conduct analytical validation of a biomarker or biomarker signature that already has a well-defined proof of concept and biological rationale. Premise and proof of concept must include evidence that the biomarker/biomarker signature has been tested in an appropriate clinical population, using either prospective or retrospective data or samples and shows sufficient sensitivity and specificity to warrant additional investment. In addition, applications to these PARs must include evidence that the detection method for the biomarker has been developed and subjected to initial evaluation of precision and analytical sensitivity. The application should clearly describe how the proposed study plans to optimize and standardize the detection method, as well as clearly define and rigorously test the analytic and pre-analytic variables to ensure broad and reliable clinical use across multiple sites.PAR-21-058 and PAR-21-059:Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders:The purpose of these Program Announcements (PAR) is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of these PARs 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. These PARs assume 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.If analytical validation of the detection method is still needed, applicants are encouraged to apply for the companion PAR, “Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 – Clinical Trial Optional)”.Research Objectives:Applications to these PARs must propose to conduct clinical validation of a biomarker or biomarker signature that already has strong proof of concept and biological rationale with evidence that the biomarker measures the concept of interest. Premise and proof of concept must include preliminary evidence that the biomarker/biomarker signature has been tested in an appropriate clinical population, using either prospective or retrospective data or samples and shows sufficient sensitivity and specificity to warrant additional investment. In addition, applications to these PARs must include evidence that the detection method for the biomarker has been analytically validated, with known performance parameters and evidence that the it can be reliably used in multiple sites using a standardized protocol.