Analysis of Clinical Trials Using SAS ― A Practical Guide

Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.

Alex Dmitrienko, PhD, is Founder and President of Mediana Inc. He is actively involved in biostatistical research with an emphasis on multiplicity issues in clinical trials, subgroup analysis, innovative trial designs, and clinical trial optimization. Dr. Dmitrienko coauthored the first edition of Analysis of Clinical Trials Using SAS: A Practical Guide, and he coedited Pharmaceutical Statistics Using SAS: A Practical Guide. Gary G. Koch, PhD, is Professor of Biostatistics and Director of the Biometrics Consulting Laboratory at the University of North Carolina at Chapel Hill. He has been active in the field of categorical data analysis for fifty years. Professor Koch teaches classes and seminars in categorical data analysis, consults in areas of statistical practice, conducts research, and trains many biostatistics students. He is coauthor of Categorical Data Analysis Using SAS, Third Edition.