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Preface
Contributors
1 Overview of Phase I Trials 1
2 Dose-Finding Designs Using Continual Reassessment Method 35
3 Choosing a Phase I Design 73
4 Overview of Phase II Clinical Trials 93
5 Designs Based on Toxicity and Response 105
6 Phase II Selection Designs 119
7 Power and Sample Size for Phase III Clinical Trials of Survival 129
8 Multiple Treatment Trials 149
9 Factorial Designs with Time-to-Event and Points 161
10 Therapeutic Equivalence Trials 173
11 Early Stopping of Cancer Clinical Trials 189
12 Use of the Triangular Test in Sequential Clinical Trials 211
13 Design and Analysis Considerations for Complementary Outcomes 229
14 Health-Related Quality-of Life Outcomes 249
15 Statistical Analysis of Quality of Life 269
16 Economic Analysis of Cancer Clinical Trials 291
17 Prognostic Factor Studies 321
18 Statistical Methods to Identify Prognostic Factors 379
19 Explained Variation in Proportional Hazards Regression 397
20 Graphical Methods for Evaluating Covariate Effects in the Cox Model 411
21 Graphical Approaches to Exploring the Effects of Prognostic Factors on Survival 433
22 Tree-Based Methods for Prognostic Stratification 457
23 Problems in Interpreting Clinical Trials 473
24 Commonly Misused Approaches in the Analysis of Cancer Clinical Trials 491
25 Dose-Intensity Analysis 503
26 Why Kaplan-Meier Fails and Cumulative Incidence Succeeds When Estimating Failure Probabilities in the Presence of Competing Risks 513
27 Meta-Analysis 525
Index 545
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