Biomarker Sample Collection and Handling in the Clinical Setting to Support Early-Phase Drug Development

The era of increased application of pharmacodynamic biomarker measures for early-phase drug development is upon us in response to the introduction to the clinic of targeted therapeutics. This unprecedented opportunity to perform measures of human physiology responding to pharmacologic intervention requires an understanding of sample collection, handling (preanalytical variables), and assay qualification for the results to be informative and allow decisions to be made on the development of the therapeutics under investigation. The literature is replete with biomarkers for many different applications from diagnostic to prognostic to pharmacodynamic. However, few studies have either described fully or even undertaken the necessary studies into each stage of the measurement of a biomarker from collection through to assay. In this chapter, we present insight into some of these issues with the aim of increasing the general understanding of the use of biomarkers in clinical development.