Main description:

All the Essentials to Start Using Adaptive Designs in No Time

Compared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to quickly and easily grasp the essence of adaptive designs as well as the foundations of adaptive design methods.

The book reduces the mathematics to a minimum and makes the material as practical as possible. Instead of providing general, black-box commercial software packages, the author includes open-source R functions that enable readers to better understand the algorithms and customize the designs to meet their needs. Readers can run the simulations for all the examples and change the input parameters to see how each input parameter affects the simulation outcomes or design operating characteristics.

Taking a learning-by-doing approach, this tutorial-style book guides readers on planning and executing various types of adaptive designs. It helps them develop the skills to begin using the designs immediately.

Contents:

Introduction. Classical Design. Two-Stage Adaptive Confirmatory Design Method. K-Stage Adaptive Confirmatory Design Methods. Sample-Size Reestimation Design. Special Two-Stage Group Sequential Trials. Pick-the-Winners Design. The Add-Arms Design. Biomarker-Adaptive Design. Response-Adaptive Randomization. Adaptive Dose-Escalation Trial. Deciding Which Adaptive Design to Use. Monitoring Trial and Making Adaptations. Data Analyses of Adaptive Trials. Planning and Execution. Appendices. Bibliography. Index.