Mark Chang

One of the first books on the topic, Adaptive Design Methods Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures based on accrued data of ongoing clinical trials. The book also offers a well-balanced summary of current regulatory perspectives, recently developed statistical methods, and practical guidelines for choosing an optimal design. Providing a broad range of adaptive design methods that use both analytical and simulation approaches, this resource fills the need for a unified, comprehensive, and updated book in the clinical research and development of adaptive design and analysis.

This book 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. It emphasizes the relationships among different methods; presents current regulatory views; discusses the challenges in planning, executing, analyzing, and reporting adaptive designs; and features Bayesian decision theory to optimize adaptive designs and programs. The author also explores controversial issues surrounding statistical theories as well as fruitful avenues for future research and applications of adaptive designs.

This book with CD–ROM introduces the Software ExpDesign Studio for classic and adaptive designs and computer simulations. The book includes step–by–step demos on creating various trial designs, using the automatic outputs to optimize the trial design, and monitoring a clinical trial in progress.

This book introduces modern methods in biostatistics and helps researchers and students quickly grasp key concepts and methods. It details novel ingredients or developments in methodology, computation algorithms and applications.