“In summary, this third edition is an impressive expansion beyond a remarkable second edition. This book would be good reference for biostatisticians, clinical researchers, and pharmaceutical scientists in clinical research and development.”  (Journal of Biopharmaceutical Statistics, 1 July 2014)

"Design and Analysis of Clinical Trials: Concepts and Methodologies, Third Edition is a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite...Essential reading for clinical research professionals." (Journal of Clinical Research Best Practice February 2014)

Preface xi

PART I PRELIMINARIES

1 Introduction 3

2 Basic Statistical Concepts 45

3 Basic Design Considerations 85

4 Randomization and Blinding 117

PART II DESIGNS AND THEIR CLASSIFICATIONS

5 Designs for Clinical Trials 165

6 Designs for Cancer Clinical Trials 211

7 Classification of Clinical Trials 237

PART III ANALYSIS OF CLINICAL DATA

8 Analysis of Continuous Data 305

9 Analysis of Categorical Data 343

10 Censored Data and Interim Analysis 389

11 Sample Size Determination 441

PART IV ISSUES IN EVALUATION

12 Issues in Efficacy Evaluation 521

13 Safety Assessment 573

PART V RECENT DEVELOPMENT

14 Biomarkers and Targeted Clinical Trials 619

15 Trials for Evaluating Accuracy of Diagnostic Devices 649

16 Statistical Methods in Translational Medicine 677

17 Adaptive Clinical Trial Designs 703

18 Traditional Chinese Medicine 733

PART VI CONDUCT OF CLINICAL TRIALS

19 Preparation and Implementation of a Clinical Protocol 755

20 Data Management of a Clinical Trial 779

References 799

Appendix A 845

Index 851