Adaptive and Flexible Clinical Trials

By enabling studies to be modified during the course of the trial, modern adaptive clinical trial designs can make studies substantially faster, more efficient, and more powerful than traditional clinical trials. The recent advances in web-based real-time data entry and novel statistical methods have made adaptive clinical trials practical and attractive. Suitable for readers involved in drug development, this is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Without using highly technical statistical jargon, it discusses the design, conduct, and execution of these trials.

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon.

Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.