Statistical Design, Monitoring, and Analysis of Clinical Trials : Principles and Methods (Hardcover, 2 ed)

1. Overview. 2. Concepts and Methods of Statistical Designs. 3. Efficiency with Trade-Offs and Crossover Designs. 4. Sample Size and Power Calculations. 5. Analysis of Covariance and Stratified Analysis. 6. Sequential Designs and Methods?Part I: Expected Sample Size and Two-Stage Phase II Trials in Oncology. 7. Sequential Designs and Methods?Part II: Monitoring Safety and Futility. 8. Sequential Designs and Methods?Part III: Classical Group Sequential Trials. 9. Monitoring the Maximum Information. Missing Data. 10. Monitoring the Maximum Information and Adaptive Sample-Size Designs. 11. Multiplicity Issues and Methods for Controlling the Type-I Error Rate. 12.Clinical Trials with Predictive Biomarkers. 13. Seamless Phase II/III: Select-the-Winner Design. 14. Statistical Significance and p-Values. 15. Estimand, Intercurrent Events, and Missing Data.