Adaptive Design Theory and Implementation Using SAS and R

Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

IntroductionClassic DesignTheory of Hypothesis-Based Adaptive DesignMethod with Direct Combination of P-valuesMethod with Inverse-Normal P-valuesAdaptive Non-Inferiority Design With Paired Binary DataTrial Design and Analysis with Incomplete Paired DataImplementation of N-Stage Adaptive DesignsConditional Error Function Method and Conditional PowerRecursive Adaptive DesignUnblinded Sample-Size Re-Estimation DesignBlinded Sample Size Re-EstimationAdaptive Design with Co-Primary EndpointMultiple-Endpoint Adaptive DesignPick-the-Winners DesignThe Add-Arms Design For Unimodal ResponseBiomarker-Adaptive DesignBiomarker-Informed Adaptive DesignSurvival Modeling and Adaptive Treatment SwitchingResponse-Adaptive Allocation DesignBayesian Adaptive Dose Finding DesignBayesian Phase I-II Adaptive DesignAdaptive Design for Biosimilarity TrialMulti-Regional Adaptive Trial DesignBayesian Adaptive DesignPlanning, Execution, Analysis, and ReportingData Analysis of Adaptive DesignDebates in Adaptive DesignsSAS Adaptive Design Modules: SEQDESIGN ProcedureAppendix A: Random Number GenerationAppendix B: A Useful Utility Appendix C: SAS Macros for Add-Arm Designs Appendix D: Implementing Adaptive Designs in R Bibliography Index