Topics in Study Design and Analysis for Multistage Clinical Proteomics Studies

This chapter discusses the design issues in clinical proteomics study and provides specific suggestions for addressing these questions when using the standard guidelines for the planning. It provides two methods for the sample size estimation in study design. The first method is used for the planning of a clinical proteomic study at the discovery or verification stage; the second method is proposed for the systematic planning of a multistage study. The second part of the chapter introduces three approaches to analyzing the clinical proteomic study and provides analyses for two case studies of clinical proteomic discoveries.