Analysis of Clinical Trials Using SAS: A Practical Guide

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SAS Institute, Feb 18, 2005 - Mathematics - 430 pages
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In Analysis of Clinical Trials Using SAS: A Practical Guide, Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, and Walter Offen bridge the gap between modern statistical methodology and real-world clinical trial applications. Step-by-step instructions illustrated with examples from actual trials and case studies serve to define a statistical method and its relevance in a clinical trials setting and to illustrate how to implement the method rapidly and efficiently using the power of SAS software. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials, including analysis of stratified data, incomplete data, multiple inferences, issues arising in safety and efficacy monitoring, and reference intervals for extreme safety and diagnostic measurements. Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience compiled in this book. Numerous ready-to-use SAS macros and example code are included. This book is part of the SAS Press program.

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Multiple Comparisons and Multiple Endpoints
Analysis of Safety and Diagnostic Data
Interim Data Monitoring
Analysis of Incomplete Data

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About the author (2005)

Alex Dmitrienko, Ph.D., is Principal Research Scientist, Eli Lilly and Company. He has been actively involved in biostatistical research and has published papers on multiple testing, group sequential inferences, and analysis of categorical data with clinical trial applications. Alex co-authored a recently published SAS Press book, Analysis of Clinical Trials Using SAS: A Practical Guide. His other interests include software implementation of new and existing statistical methods.

Geert Molenberghs, Ph.D., Professor of Biostatistics, Center for Statistics, Limburgs Universitair Centru, Belgium, has published on incomplete and longitudinal data and is co-author, together with Geert Verbeke, of books on longitudinal data analysis, mixed models and incomplete data. He has acted as a consultant for several pharmaceutical companies, research institutes and the government.

Christy Chuang-Stein, Ph.D., Senior Director of the Statistical Research and Consulting Center at Pfizer, has more than 20 years of experience in the pharmaceutical industry. She has more than 80 publications in statistical and medical journals. In addition to technical subjects dealing with statistical theory and applications, she is also interested in the development of pharmaceutical statisticians and the statistics profession in general.

Walter W. Offen, Ph.D., Research Fellow, Eli Lilly and Company, has more than 20 years of experience in clinical trials for numerous therapeutic areas. He led a development team at Lilly to create a SAS-based analysis system for clinical trials, which is still in use today. He has been involved with Pharmaceutical Research and Manufacturers of America (PhRMA) and participated in or led several PhRMA expert teams.

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