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Analysis of Clinical Trials Using SAS: A Practical Guide

About the Book

Analysis of Clinical Trials Using SAS: A Practical Guide By: Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, and Walter Offen ISBN: 978-1-59047-504-1 Pages: 440 Order this book from our online bookstore

This book concentrates on the most important problems arising in the context of clinical trials and medical research in general. It discusses solutions to these problems based on modern statistical methods and reviews SAS techniques that help clinical researchers efficiently and rapidly implement these methods. The choice of topics reflects the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry. This book follows these recommendations and discusses the analysis of stratified data, incomplete data, multiple inferences, and issues arising in interim safety and efficacy monitoring. It also addresses other statistical problems that are very important in a clinical trials setting, including reference intervals for extreme safety and diagnostic measurements.

About the Authors

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.

Walter W. Offen, Ph.D., Research Fellow, Eli Lilly and Company, has 23 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.

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.

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.