Best Practices in Translational Biomarker Data Analysis

BEST PRACTICES IN TRANSLATIONAL BIOMARKER DATA ANALYSIS 

In 2014, the FDA issued a guidance document on the qualification of drug development tools (DDTs) (FDA, US Food and Drug Administration, 2014) that included biomarkers within its scope and detailed a process for qualifying DDTs for potential use in multiple clinical drug development programs within a specified context of use (COU). Specific 

A generic operational strategy to qualify translational safety biomarkers using a two-stage approach of (Jenkins et al., 2011) initial exploratory studies to identify and characterize candidate biomarkers followed by (Eosho et al., 2012) confirmatory studies to build upon the evidence of the initial studies has been described (Matheis et al., 2011). We highlight key statistical considerations in these contexts. 

Drug Discovery Toxicology From Target Assessment to Translational Biomarkers, First Edition. Edited by Yvonne Will, J. Eric McDuffie, Andrew J. Olaharski, and Brandon D. Jeffy. 

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