Design and Analysis of Cross-Over Trials
1st Edition
Published on 12. March 2003
Book
Hardback
408 pages
978-0-412-60640-3 (ISBN)
Description
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.
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.
More details
Edition
1., 998
Language
English
Place of publication
London
United Kingdom
Target group
College/higher education
Professional and scholarly
Research
Edition type
New edition
Illustrations
35 s/w Abbildungen, 172 s/w Tabellen
172 Tables, black and white; 35 Illustrations, black and white
Dimensions
Height: 229 mm
Width: 152 mm
Weight
1 gr
ISBN-13
978-0-412-60640-3 (9780412606403)
Schweitzer Classification
Other editions
New editions
Byron Jones | Michael G. Kenward
Design and Analysis of Cross-Over Trials
Book
10/2014
3rd Edition
Chapman & Hall/CRC
€167.30
Shipment within 15-20 days
Previous edition
Byron Jones | Michael G. Kenward
Design and Analysis of Cross-Over Trials
Book
06/1989
1st Edition
Chapman & Hall/CRC
€60.65
Article exhausted; check for reprint
Content
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
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