Analysis of Clinical Trials Using SAS: A Practical Guide Dmitrienko, Alex; Molenberghs, Geert; Offen, Walter and Chuang-Stein, Christy

This comprehensive guide bridges 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 Analysis of Clinical Trials Using SAS: A Practical Guide. Numerous ready-to-use SAS macros and example code are included.

Alex Dmitrienko, Ph.D., is Principal Research Scientist at Eli Lilly and Company. Actively involved in biostatistical research, Alex has published papers on multiple testing, group sequential inferences, and analysis of categorical data with clinical trial applications. His other professional interests include software implementation of new and existing statistical methods.

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

Christy Chuang-Stein, Ph.D., is Senior Director of the Statistical Research and Consulting Center at Pfizer. She has more than 20 years of experience in the pharmaceutical industry and has published over 80 papers in statistical and medical journals. Christy's professional interests include technical subjects relating to statistical theory and applications as well as the development of pharmaceutical statistics and the general statistics profession.

Walter Offen, Ph.D., is Research Fellow at Eli Lilly and Company and has 23 years of experience in clinical trials for numerous therapeutic areas. Walter led a development team at Lilly that created an analysis system for clinical trials that was based on SAS software and is still in use today. He has been involved with Pharmaceutical Research and Manufacturers of America (PhRMA) and has participated in or led several PhRMA expert teams.