INTRODUCTION
What is a Cross-Over Trial?
With which Sort of Cross-Over Trial are We Concerned?
Why Do Cross-Over Trials Need Special Consideration?
A Brief History
Notation, Models and Analysis
Aims of this Book
Structure of the Book
THE 2 x 2 CROSS-OVER TRIAL
Introduction
Plotting the Data
The Analysis Using t-Tests
Sample Size Calculations
The Analysis of Variance
Aliasing of Effects
Consequences of preliminary testing
Analyzing the residuals
A Bayesian Analysis of the 2 x 2 Trial
The Use of Baseline Measurements
The Use of Covariates
Nonparametric Analysis
Binary Data
HIGHER-ORDER DESIGNS FOR TWO TREATMENTS
Introduction
’Optimal’ Designs
Balaam’s Design for Two Treatments
The Effect of Preliminary Testing in Balaam’s Design
Three-Period Designs with Two Sequences
Three-Period Designs with Four Sequences
A Three-Period Six-Sequence Design
Which Three-Period Design to Use?
Four-Period Designs with Two Sequences
Four-Period Designs with Four Sequences
Four-Period Designs with Six Sequences
Which Four-Period Design to Use?
Which Two-Treatment Design to Use?
DESIGNING CROSS-OVER TRIALS FOR THREE OR MORE TREATMENTS
Introduction
Variance-Balanced Designs
Optimality Results for Cross-Over Designs
Which Variance Balanced Design to Use?
Partially Balanced Designs
Comparing Test Treatments to a Control
Factorial Treatment Combinations
Extending the Simple Model for Carry-Over Effects
Computer Search Algorithms
ANALYSIS OF CONTINUOUS DATA
Introduction
The Fixed Subject Effects Model
The Random Subject Effects Model
Analyses for Higher-Order Two-Treatment Designs
The General Linear Mixed Model
Analysis of Repeated Measurements within Periods
Cross-Over Data as Repeated Measurements
Case Study: an Analysis of a Trial with Many Periods
ANALYSIS OF CATEGORICAL DATA
Introduction
Binary Data: Subject Effect Models
Binary Data: Marginal Models
Categorical Data
Further Topics
BIOEQUIVALENCE TRIALS
What is Bioequivalence
Testing for Average Bioequivalence
Power and Sample Size for ABE in the 2 x 2 Design
Individual Bioequivalence
Population Bioequivalence
ABE for a Replicate Design
Kullback–Leibler Divergence for Evaluating Bioequivalence
Modelling Pharmacokinetic Data
APPENDICES
Least Squares Estimation
SAS Code for Assessing ABEm IBE, and PBE in Replicate Cross-Over Trials
REFERENCES
"In the second edition, updated from the original published in 1989, the authors have added discussions of new more comprehensive (downloadable) datasets and some additional topics... Substantially updated with more than 130 new references, the book has been thoroughly modernized to reflect new developments in this area. Among the new material added to the book are a chapter on bioequivalence and a discussion of new methods for longitudinal and categorical data. This book continues to be a recommended choice as a valuable reference for clinical statisticians and those who study medical trials where treatments through cross-over design are a feasible approach. For those who already own the first edition, updating to the second will help keep you current on recent developments in this area." -Journal of the American Statistics Association, March 2004 Praise for the First Edition: ..."this book will remain the standard reference on the subject for decades to come." -Mathematical Gazette ..."a refreshing mixture of theory and practice...This book will be useful to all medical statisticians and anyone else involved in cross-over trials. It is pitched at a level suitable not only for practitioners, but for senior and postgraduate students as well." -Short Book Reviews of the ISI
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