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“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
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