Workflow for Circulating miRNA Identification and Development in Cancer Research: Methodological Considerations

Abstract This chapter presents the issues related to the biomarker development process, including the statistical ones. It starts by introducing the biomarker concepts, and then, it is focused on the miRNA-based studies, highlighting also the challenges related to their identification. Furthermore, it is focused on the study design and to the statistical-methodological aspects related to their identification and combination in a composite score, with special reference to the colorectal cancer screening setting.