Clinical Trials 3e

By Jen-Pei Liu and Shein-Chung Chow

Praise for the Second Edition:

"...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." --Journal of Clinical Research Best Practices

The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include:

- New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine

- A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies

- Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts

- New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation

- A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines

- An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development

Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

• Format: Hardcover
• Language: English
• ISBN: 0470887656
• ISBN13: 9780470887653
• Release Date: November 2013
• Publisher: Wiley
• Length: 892 Pages
• Weight: 3.65 lbs.
• Dimensions: 1.7" x 7.2" x 10.0"

Customer Reviews

good practical treatment covering FDA guidelines and ICH guidelines as well

The authors have experience conducting clinical trials in the pharmaceutical industry and this shows in their approach. All the issues that arise in an NDA submission to the FDA are covered. In the introduction the authors describe the regulatory process and the role of the FDA. They even provide organizational charts for the FDA Center for Drug Evaluation and Research. I have been working as a senior biostatistician for medical device companies for the last 5 years. Most of the trials I have worked on were regulated by the FDA and a number of issues that have been important to the FDA include (1) multiple comparisons, (2) intention-to-treat versus per protocol analysis, (3) pooling centers, (4) baseline data and demographics, (5) data monitoring and (6) safety. They are all covered in chapters 11 and 12 of this book. Chapter 10 emphasizes sample size determination and interim analyses are covered in chapter 9. Randomization and blinding are covered in chapter 4. These topics are emphasized because of their importance in regulated clinical trials. One does not find them covered very much in other statistics texts on survival analysis or clinical trials. The mathematics level is intermediate. The authors write well and incorporate the important practical interplay between the statistician, the clinician and the physician. They provide many good references. The book is a good reference for anyone interested in clinical trials. Points are illustrated through the use of real trials. Recent advances in Bayesian methods, resampling and meta analysis are not covered but most important topics are covered including group sequential methods.