Description
Book SynopsisA balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics.
Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a
Trade Review
“In summary, this book is useful for anyone interested in design and analysis of clinical studies. The main strengths of this book are the well-balanced approach between statistical theories and statistical analysis methods of the design issues involved in clinical trials. I would suggest the usage of this book as a Master’s level course in biostatistics.” (Journal of Biopharmaceutical Statistics, 1 May 2013)
“The author should be commended; the text is well written and packed with information that belies the book’s trim size." (Drug Information Journal, 30 October 2012)
“The book accompanied with software developed at MD Anderson Cancer Center provides an excellent reference for everyone who works in clinical trial field.” (Biometrics, 1 July 2012)
Table of ContentsPreface xv
1. Introduction 1
2. Fundamentals of Clinical Trials 13
3. Frequentist versus Bayesian Statistics 29
4. Phase I Trial Design 77
5. Phase II Trial Design 115
6. Phase III Trial Design 159
7. Adaptive Randomization 223
8. Late-Onset Toxicity 253
9. Drug-Combination Trials 271
10. Targeted Therapy Design 297
References 311
Author Index 329
Subject Index 333
