Adaptive Design Theory and Implementation Using SAS and R

Adaptive design has become an important tool in modern pharmaceutical research and development. Compared to a classic trial design with static features, an adaptive design allows for the modification of the characteristics of ongoing trials based on cumulative information. Adaptive designs increase the probability of success, reduce costs and the time to market, and promote accurate drug delivery to patients.
Reflecting the state of the art in adaptive design approaches, Adaptive Design Theory and Implementation Using SAS and R provides a concise, unified presentation of adaptive design theories, uses SAS and R for the design and simulation of adaptive trials, and illustrates how to master different adaptive designs through real-world examples. The book focuses on simple two-stage adaptive designs with sample size re-estimation before moving on to explore more challenging designs and issues that include drop-loser, adaptive dose-funding, biomarker-adaptive, multiple-endpoint adaptive, response-adaptive randomization, and Bayesian adaptive designs. In many of the chapters, the author compares methods and provides practical examples of the designs, including those used in oncology, cardiovascular, and inflammation trials.
Equipped with the knowledge of adaptive design presented in this book, you will be able to improve the efficiency of your trial design, thereby reducing the time and cost of drug development.

Preface. Introduction. Classic Design. Theory of Adaptive Design. Method with Direct Combination of P-Values. Method with Inverse-Normal P-Values. Implementation of N-Stage Adaptive Designs. Conditional Error Function Method. Recursive Adaptive Design. Sample Size Adjustment. Multiple-Endpoint Adaptive Trials. Drop-Loser and Add-Arm Designs. Biomarker-Adaptive Design. Adaptive Treatment Switching and Crossover. Response-Adaptive Allocation Design. Adaptive Dose Finding Trial. Bayesian Adaptive Design.Planning, Execution, Analysis, and Reporting. Paradox—Debates in Adaptive Designs. Appendices. Bibliography. Index.