ABSTRACT
This chapter discusses several procedures for sample size calculation based on different study objectives and/or hypotheses using different statistical methods. It examines sample size calculations for QT/QTc studies with time-dependent replicates. A typical study design for QT studies is either a parallel-group design or a crossover design depending upon the primary objectives of the study. The chapter provides sample size calculation based on propensity score analysis for nonrandomized studies. It also discusses sample size calculation under an analysis of variance (ANOVA) model with repeated measures. The chapter introduces the concept of reproducibility and sensitivity index for bridging studies. It explains sample size calculation for the assessment of quality of life (QOL) under a time series model. The chapter describes the proposed method for assessing the similarity of bridging studies, which is used for the derivation of a procedure for sample size calculation. It outlines statistical methods and the corresponding procedure for sample size calculation for vaccine clinical trials.
