Covering even more adaptive designs, this second edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. It includes 12 new chapters, more analytical methods, 20 new SAS macros and R functions, and enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials. The book compares various methods using SAS and R simulations and explains how to analyze data in adaptive trials.
Covering even more adaptive designs, this second edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. It includes 12 new chapters, more analytical methods, 20 new SAS macros and R functions, and enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials. The book compares various methods using SAS and R simulations and explains how to analyze data in adaptive trials.
Introduction. Classic Design. Theory of Hypothesis Based Adaptive Design. Method with Direct Combination of P Values. Method with Inverse Normal P Values. Adaptive Non Inferiority Design with Paired Binary Data. Trial Design and Analysis with Incomplete Paired Data. Implementation of N Stage Adaptive Designs. Conditional Error Function Method and Conditional Power. Recursive Adaptive Design. Unblinded Sample Size Re Estimation Design. Blinded Sample Size Re Estimation. Adaptive Design with Co Primary Endpoint. Multiple Endpoint Adaptive Design. Pick the Winners Design. The Add Arms Design for Unimodal Response. Biomarker Adaptive Design. Biomarker Informed Adaptive Design. Survival Modeling and Adaptive Treatment Switching. Response Adaptive Allocation Design. Bayecian Adaptive Dose Finding Design. Bayesian Phase I II Adaptive Design. Adaptive Design for Biosimilarity Trial. Multi Regional Adaptive Trial Design. Bayesian Adaptive Design. Planning, Execution, Analysis, and Reporting. Data Analysis of Adaptive Design. Debates in Adaptive Designs. SAS Adaptive Design Modules: SEQDESIGN Procedure. Appendices. Bibliography. Index.
Introduction. Classic Design. Theory of Hypothesis Based Adaptive Design. Method with Direct Combination of P Values. Method with Inverse Normal P Values. Adaptive Non Inferiority Design with Paired Binary Data. Trial Design and Analysis with Incomplete Paired Data. Implementation of N Stage Adaptive Designs. Conditional Error Function Method and Conditional Power. Recursive Adaptive Design. Unblinded Sample Size Re Estimation Design. Blinded Sample Size Re Estimation. Adaptive Design with Co Primary Endpoint. Multiple Endpoint Adaptive Design. Pick the Winners Design. The Add Arms Design for Unimodal Response. Biomarker Adaptive Design. Biomarker Informed Adaptive Design. Survival Modeling and Adaptive Treatment Switching. Response Adaptive Allocation Design. Bayecian Adaptive Dose Finding Design. Bayesian Phase I II Adaptive Design. Adaptive Design for Biosimilarity Trial. Multi Regional Adaptive Trial Design. Bayesian Adaptive Design. Planning, Execution, Analysis, and Reporting. Data Analysis of Adaptive Design. Debates in Adaptive Designs. SAS Adaptive Design Modules: SEQDESIGN Procedure. Appendices. Bibliography. Index.
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