ABSTRACT

Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture.T

Introduction. The 2 Cross-Over Trial. Higher-Order Designs for Two Treatments. Designing Cross-Over Trials. Analysis of Continuous Data. Analysis of Discrete Data. Bioequivalence Trials. Case Study: Phase I Dose-Response Noninferiority Trial. Case Study: Choosing a Dose-Response Model. Case Study: Conditional Power. Case Study: Proof of Concept Trial with Sample Size Re-Estimation. Case Study: Blinded Sample Size Re-Estimation in a Bioequivalence Study. Case Study: Unblinded Sample Size Re-Estimation in a Bioequivalence Study That Has a Group Sequential Design. Case Study: Various Methods for an Unblinded Sample Size Re-Estimation in a Bioequivalence Study. Appendix A: Least Squares Estimation. Bibliography.