Analysis of Clinical Trials Using SAS, A Practical Guide

Preface......Page 9
About This Book......Page 19
About These Authors......Page 23
1 Model-based and Randomization-based Methods By Alex Dmitrienko and Gary G. Koch......Page 25
1.1 Introduction......Page 26
1.2 Analysis of continuous endpoints......Page 31
1.3 Analysis of categorical endpoints......Page 58
1.4 Analysis of time-to-event endpoints......Page 94
1.5 Qualitative interaction tests......Page 120
References......Page 128
2 Advanced Randomization-based Methods By Richard C. Zink, Gary G. Koch, Yunro Chung and Laura Elizabeth Wiener......Page 136
2.1 Introduction......Page 137
2.2 Case studies......Page 141
2.3 %NParCov4 macro......Page 146
2.4 Analysis of ordinal endpoints using a linear model......Page 148
2.5 Analysis of binary endpoints......Page 156
2.6 Analysis of ordinal endpoints using a proportional odds model......Page 158
2.7 Analysis of continuous endpoints using the log-ratio of two means......Page 160
2.8 Analysis of count endpoints using log-incidence density ratios......Page 162
2.9 Analysis of time-to-event endpoints......Page 163
2.10 Summary......Page 171
3 Dose-Escalation Methods By Guochen Song, Zoe Zhang, Nolan Wages, Anastasia Ivanova, Olga Marchenko and Alex Dmitrienko......Page 195
3.1 Introduction......Page 196
3.2 Rule-based methods......Page 198
3.3 Continual reassessment method......Page 206
3.4 Partial order continual reassessment method......Page 221
References......Page 233
4 Dose-finding Methods By Srinand Nandakumar, Alex Dmitrienko and Ilya Lipkovich......Page 237
4.1 Introduction......Page 238
4.2 Case studies......Page 239
4.3 Dose-response assessment and dose-finding methods......Page 245
4.4 Dose finding in Case study 1......Page 268
4.5 Dose finding in Case study 2......Page 295
References......Page 323
5 Multiplicity Adjustment Methods By Thomas Brechenmacher and Alex Dmitrienko......Page 327
5.1 Introduction......Page 328
5.2 Single-step procedures......Page 336
5.3 Procedures with a data-driven hypothesis ordering......Page 344
5.4 Procedures with a prespecified hypothesis ordering......Page 367
5.5 Parametric procedures......Page 383
5.6 Gatekeeping procedures......Page 397
References......Page 432
Appendix......Page 437
6.1 Introduction......Page 446
6.2 Repeated significance tests......Page 450
6.3 Stochastic curtailment tests......Page 519
References......Page 559
7 Analysis of Incomplete Data By Geert Molenberghs and Michael G. Kenward......Page 566
7.1 Introduction......Page 567
7.2 Case Study......Page 571
7.3 Data Setting and Methodology......Page 575
7.4 Simple Methods and MCAR......Page 593
7.5 Ignorable Likelihood (Direct Likelihood)......Page 601
7.6 Direct Bayesian Analysis (Ignorable Bayesian Analysis)......Page 608
7.7 Weighted Generalized Estimating Equations......Page 611
7.8 Multiple Imputation......Page 621
7.9 An Overview of Sensitivity Analysis......Page 643
7.10 Sensitivity Analysis Using Local Influence......Page 646
7.11 Sensitivity Analysis Based on Multiple Imputation and Pattern-Mixture Models......Page 660
7.12 Concluding Remarks......Page 672
References......Page 673
Index......Page 682