Introduction Motivation Adaptive Designs in Clinical Trials Clinical Trial Simulation Characteristics of Adaptive Designs FAQs about Adaptive Designs Classical Design Introduction Two-Group Superiority Two-Group Noninferiority Trial Two-Group Equivalence Trial Trial with Any Number of Groups Multigroup Dose-Finding Trial Summary and Discussion Two-Stage Adaptive Confirmatory Design Method General Formulation Method Based on Sum of p -Values Method with Product of p -Values Method with Inverse-Normal p -Values Comparisons of Adaptive Design Methods K -Stage Adaptive Confirmatory Design Methods Test Statistics Determination of Stopping Boundary Error-Spending Function Power and Sample Size Error Spending Approach Sample-Size Reestimation Design Sample Size Reestimation Methods Comparisons of SSR Methods K -Stage Sample Size Reestimaion Trial Summary Special Two-Stage Group Sequential Trials Event-Based Design Equivalence Trial Adaptive Design with Farrington-Manning Margin Noninferiority Trial with Paired Binary Data Trial with Incomplete Paired Data Trial with Coprimary Endpoints Trial with Multiple Endpoints Pick-the-Winners Design Overview of Multiple-Arm Designs Pick-the-Winner Design Stopping Boundary and Sample Size Summary and Discussion The Add-Arms Design Introduction The Add-Arm Design Clinical Trial Examples Extension of Add-Arms Designs Summary Biomarker-Adaptive Design Taxonomy Biomarker-Enrichment Design Biomarker-Informed Adaptive Design Summary Response-Adaptive Randomization Basic Response-Adaptive Randomizations Generalized Response-Adaptive Randomization Summary and Discussion Adaptive Dose-Escalation Trial Oncology Dose-Escalation Trial Continual Reassessment Method Alternative Form CRM Evaluation of Dose-Escalation Design Summary and Discussion Deciding Which Adaptive Design to Use Determining the Objectives Determining Design Parameters Evaluation Matrix of Adaptive Design Monitoring Trials and Making Adaptations Stopping and Arm-Selection Conditional Power Sample-Size Reestimation New Randomization Scheme Data Analyses of Adaptive Trials Orderings in Sample Space Adjusted p -Value Parameter Estimation Confidence Interval Summary Planning and Execution Study Planning Working with a Regulatory Agency Trial Execution Summary Appendix A: Thirty-Minute Tutorial to R Appendix B: R Functions for Adaptive Designs Bibliography Index.