Main description:

Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.

Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed.

This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example.

Watch the author speak about this book at JSM 2012 in San Diego.

Contents:

Introduction. Seven Key Steps to Cook up a Sample Size. Sample Sizes for Parallel Group Superiority Trials with Normal Data. Sample Size Calculations for Superiority Crossover Trials with Normal Data. Sample Size Calculations for Equivalence Clinical Trials with Normal Data. Sample Size Calculations for Non-Inferiority Clinical Trials with Normal Data. Sample Size Calculations for Bioequivalence Trials. Sample Size Calculations for Precision-Based Clinical Trials with Normal Data. Sample Size Calculations for Parallel Group Superiority Clinical Trials with Binary Data. Sample Size Calculations for Superiority Crossover Clinical Trials with Binary Data. Sample Size Calculations for Non-Inferiority Trials with Binary Data. Sample Size Calculations for Equivalence Trials with Binary Data. Sample Size Calculations for Precision-Based Trials with Binary Data. Sample Size Calculations for Clinical Trials with Ordinal Data. Sample Size Calculations for Clinical Trials with Survival Data. References. Appendix.