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 variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include:
Risk and benefit analysis for toxicity and efficacy trade-offs
Bayesian predictive probability trial monitoring
Bayesian adaptive randomization
Late onset toxicity and response
Dose finding in drug combination trials
Targeted therapy designs
The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials.
Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
Content:Chapter 1 Introduction (pages 1–11):
Chapter 2 Fundamentals of Clinical Trials (pages 13–28):
Chapter 3 Frequentist versus Bayesian Statistics (pages 29–76):
Chapter 4 Phase I Trial Design (pages 77–114):
Chapter 5 Phase II Trial Design (pages 115–157):
Chapter 6 Phase III Trial Design (pages 159–221):
Chapter 7 Adaptive Randomization (pages 223–252):
Chapter 8 Late?Onset Toxicity (pages 253–270):
Chapter 9 Drug?Combination Trials (pages 271–295):
Chapter 10 Targeted Therapy Design (pages 297–309):