title: Topics in Study Design and Analysis for Multistage Clinical Proteomics Studies.
abstract: 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.
authors.affiliation: The Department of Statistics, The University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. datalabsim@gmail.com.
authors.forename: Irene Sui Lan
authors.initials: IS
authors.lastname: Zeng
mesh_terms: D035843:Biomedical Research / Q000379:methods* / Q000592:standards*; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D006801:Humans; D040901:Proteomics / Q000379:methods*; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size
keywords: Checklist for planning; Sample size estimation; Statistical analysis for a clinical proteomic study; Study design for discovery; Verification and validation