This book provides an excellent overview of many statistical methods used in clinical trial design and data analysis. It is much more than a collection of SAS programs. The authors share their experience as shown in the examples and discussions that give an in-depth insight of many practical problems you may face in the real world.
For the non-statistician, the array of statistical issues in design and analysis of clinical trials can be overwhelming. Drawing on their years of experience dealing with data analysis plans and the regulatory environment, the authors of Analysis of Clinical Trials Using SAS: A Practical Guide have done a great job in organizing the statistical issues one needs to consider. These issues need to be considered both in the design phase and in the analysis and reporting phase. As the authors demonstrate, SAS provides excellent tools for design, analysis, and reporting the results of comparative trials, making this book very attractive for the non-statistician.
This book will also be very useful for statisticians who wish to learn the most current statistical methodologies in clinical trials. The authors make use of recent developments in SAS, including stratification, multiple imputation, mixed models, nonparametrics, and multiple comparisons procedures, to provide cutting-edge tools that are either difficult to find or unavailable in other software packages. Statisticians will also appreciate the fact that sufficient technical details are provided.
Because clinical trials are so highly regulated, some of the most rigorous and highly respected statistical tools are used in this arena. The methodologies covered in this book have applicability to the design and analysis of experiments well beyond clinical trials; researchers in all fields who carry out comparative studies would do well to have it on their bookshelves.
Texas Tech University
This book covers many important topics applied biostatisticians encounter every day. It will be a big addition to the existing literature on the analysis of clinical trials using SAS, and I expect this book is much needed. The feature I like most about Analysis of Clinical Trials Using SAS: A Practical Guide is that it not only gives comprehensive reviews and summaries of developments on several very important topics, but also provides practical guide on how the methodologies can be implemented in the SAS environment. I strongly agree with the authors that the experienced biostatisticians who are involved in the design and analysis of clinical trials will find the book very helpful, as will graduate students specializing in biostatistics.
Xiaoming Li, Ph.D.
Merck Research Laboratories
This is a very impressive book. Although it doesn't pretend to cover all types of analyses used in clinical trials, it does provide unique coverage of five extremely important areas. Each chapter combines a detailed literature review and theoretical development along with a useful how-to guide for practitioners. This will be a valuable book for clinical biostatisticians in the pharmaceutical industry.
Chapter 1, 'Analysis of Stratified Data,' will make a very fine and useful addition to the literature on analyzing clinical trials using SAS.
University of Glasgow
Chapter 2, 'Multiple Comparisons and Multiple Endpoints,' provides an excellent single-source overview of the statistical methods available to address the critically important aspect of multiplicity in clinical trial evaluation. The treatment is comprehensive, and the authors compare and contrast methods in specific applications. Newly developed gatekeeping methods are included, and the available software makes the approach accessible. The graphical displays are particularly useful in understanding the concept of adjusted p-values.
Analysis of Clinical Trials Using SAS: A Practical Guide is a complete and thorough analysis of the types of data used in clinical trials, the statistics needed to evaluate the data, and the SAS code that can be used to analyze the data. This book is a 'must read' for the statistician who is tasked with analyzing clinical data.
Janet E. Stuelpner
Left Hand Computing, Inc.
Analysis of Clinical Trials Using SAS®: A Practical Guide is a very useful reference book for statisticians and SAS users working in clinical trials. The book provides relevant examples and statistical methods, corresponding SAS codes, analysis results, and particular comments on statistical methods and data analysis. Statisticians are guided in selecting the appropriate statistical models and SAS procedures to perform data analysis. The SAS procedures and codes shown can also be used in applications far beyond the five challenging and important topics covered in this book.
Zhonqxin Zhang, Ph.D.
Merck & Co.
I found Analysis of Clinical Trials Using SAS®: A Practical Guide to be an excellent SAS book that focuses on the statistical analysis of clinical trial data. The authors do a great job of explaining many important statistical methods used in clinical data analysis and also show well-thought out examples with complete SAS codes that can be directly employed to solve many real-life problems. I love this book and would recommend it to anybody who regularly uses statistics in a clinical trial context.
Merck & Co.