Senior Director, Head of Statistical Bioinformatics GlaxoSmithKline Souderton, Pennsylvania
Biomarkers in medical research and drug development are used for a wide variety of applications such as disease diagnosis, clinical trial patient selection, enrichment, pharmacodynamic evaluations, prediction of treatment response, safety events and precision medicine. The types of biomarkers vary across a broad spectrum that include for example, imaging, histopathology, genetic, mRNA and protein expression, and a wide variety of analytical methods are quantifying these biomarkers. A key consideration in establishing the suitability of a biomarker analytical method and measurement for a context of use relates to the analytical and physiological variability of biomarker measurements. In this talk, recommendations will be provided for the evaluation of these variability measures, and the setting of minimal acceptable precision and maximum tolerable precision. Their use in defining the method acceptance for a specific context of use will then be illustrated for different scenarios.
Understand the impact of varying levels of analytical and physiological variability in the utility of biomarkers in different applications.
Define fit-for-purpose suitability of biomarker methods based on the analytical and physiological variability and context of use.
Establish minimum adequate precision and maximum tolerable imprecision of a biomarker method for a specific context of use.