Design and Analysis of Cross-Over Trials, Second Edition: (Chapman & Hall/CRC Monographs on Statistics & Applied Probability)

The first edition of Design and Analysis of Cross-Over Trials quickly became the standard reference on the subject and has remained so for more than 12 years. In that time, however, the use of cross-over trials has grown rapidly, particularly in the pharmaceutical arena, and researchers have made a number of advances in both the theory and methods applicable to these trials. Completely revised and updated, the long-awaited second edition of this classic text retains its predecessor's careful balance of theory and practice while incorporating new approaches, more data sets, and a broader scope. Enhancements in the second edition include: A new chapter on bioequivalence Recently developed methods for analyzing longitudinal continuous and categorical data Real-world examples using the SAS system A comprehensive catalog of designs, datasets, and SAS programs available on a companion Web site at www.crcpress.com The authors' exposition gives a clear, unified account of the design and analysis of cross-over trials from a statistical perspective along with their methodological underpinnings. With SAS programs and a thorough treatment of design issues, Design and Analysis of Cross-Over Trials, Second Edition sets a new standard for texts in this area and undoubtedly will be of direct practical value for years to come.

Table of Contents:
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

Review :
"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