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Analysis of Clinical Trials
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Analysis of Clinical Trials
by Geert Molenberghs, Walter W. Offen, Christy Chuang-Stein, Alex Dmitrienko
Analysis of Clinical Trials Using SAS
1 Analysis of Stratified Data
1.1 Introduction
1.2 Continuous Endpoints
1.3 Categorical Endpoints
1.4 Time-to-Event Endpoints
1.5 Tests for Qualitative Interactions
2 Multiple Comparisons and Multiple
2.1 Introduction
2.2 Single-Step Tests
2.3 Closed Testing Methods
2.4 Fixed-Sequence Testing Methods
2.5 Resampling-Based Testing Methods
2.6 Testing Procedures for Multiple Endpoints
2.7 Gatekeeping Strategies
3 Analysis of Safety and Diagnostic Data
3.1 Introduction
3.2 Reference Intervals for Safety and Diagnostic Measures
3.3 Analysis of Shift Tables
4 Interim Data Monitoring
4.1 Introduction
4.2 Repeated Significance Tests
4.3 Stochastic Curtailment Tests
5 Analysis of Incomplete Data
5.1 Introduction
5.2 Case Studies
5.3 Data Setting and Modeling Framework
5.4 Analysis of Complete Growth Data
5.5 Simple Methods and MCAR
5.6 Available Case Methods
5.7 Likelihood-Based Ignorable Analyses
5.8 Multiple Imputation
5.9 The EM Algorithm
5.10 Categorical Data
5.11 MNAR and Sensitivity Analysis
5.12 Summary
Appendix
References
Index
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