Design and Analysis of Clinical Trials: Concept and Methodologies (Wiley Series in Probability and Statistics)

By Jen-Pei Liu and Shein-Chung Chow

Book Overview

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.

• Format: Hardcover
• Language: English
• ISBN: 047113404X
• ISBN13: 9780471134046
• Release Date: June 1998
• Publisher: Wiley-Interscience
• Length: 672 Pages
• Weight: 2.45 lbs.
• Dimensions: 9.6" x 1.4" x 6.4"

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.