Statistical Approaches for Clinical Trials Introduction Comparisons between Bayesian and frequentist approaches Adaptivity in clinical trials Features and use of the Bayesian adaptive approach Basics of Bayesian Inference Introduction to Bayes' theorem Bayesian inference Bayesian computation Hierarchical modeling and metaanalysis Principles of Bayesian clinical trial design Appendix: R Macros Phase I Studies Rule-based designs for determining the MTD Model-based designs for determining the MTD Efficacy versus toxicity Combination therapy Appendix: R Macros Phase II Studies Standard designs Predictive probability Sequential stopping Adaptive randomization and dose allocation Dose ranging and optimal biologic dosing Hierarchical models for Phase II designs Decision theoretic designs Case studies: BATTLE and ISPY-2 Appendix: R Macros Phase III Studies Introduction to confirmatory studies Bayesian adaptive confirmatory trials Arm dropping Modeling and prediction Prior distributions and the paradigm clash Phase III cancer trials Phase II/III seamless trials Case study: Ablation device to treat atrial fibrillation Appendix: R Macros Special Topics Incorporating historical data Equivalence studies Multiplicity Subgroup analysis Appendix: R Macros References Author Index Subject Index
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