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Analysis of Clinical Trials Using SAS: A
Practical Guide
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Written by
Alex Dmitrienko
Principal Research Scientist
Eli Lilly and Company
Geert Molenberghs
Professor of Statistics
Hasselt University
Christy Chuang-Stein
Executive Director
Pfizer
Walt Offen
Senior Research Fellow
Eli Lilly and Company
Copyright © 2005 SAS Institute Inc.
Used with permission.
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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 that 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 the important statistical problems encountered
in clinical trials, including analysis of stratified data, analysis
of incomplete data, multiple inferences, issues arising in safety
and efficacy monitoring, 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.
Chapter 1. Analysis of Stratified Data.
Chapter 2. Multiple Comparisons and Multiple
Endpoints.
Chapter 3. Analysis of Safety and Diagnostic
Data.
Chapter 4. Interim Data Monitoring.
Chapter 5. Analysis of Incomplete Data.
Peter H. Westfall, Professor of Statistics,
Texas Tech University
This book will 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. Researchers in all fields who carry
out comparative studies would do well to have the book on their
bookshelves.
Gordon Lan, Senior Director, Biometrics and
Clinical Informatics, Johnson and Johnson
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 in examples and discussions
that give an in-depth insight into many practical problems you
may face in the real world.
Analysis of clinical trials (Christy Chuang-Stein,
Alex Dmitrienko, Geert Molenberghs). Full-day course at Joint
Statistical Meetings, Minneapolis, 2005. The training course received
the prestigious ASA Excellence in Continuing Education Award.
Multiplicity issues in clinical trials (Alex
Dmitrienko). Half-day course at Deming Conference, Atlantic City,
2005.
Analysis of clinical trials (Christy Chuang-Stein,
Alex Dmitrienko, Geert Molenberghs). Full-day course at Joint
Statistical Meetings, Seattle, 2006.
Multiple comparisons and multiple endpoints
in clinical trials (Alex Dmitrienko). Half-day course, ASA LearnSTAT
series, Princeton, 2007.
Analysis of clinical trials (Christy Chuang-Stein,
Alex Dmitrienko, Geert Molenberghs). Full-day course at Joint
Statistical Meetings, Salt Lake City, 2007.
Other books by the authors Pharmaceutical
Statistics Using SAS: A Practical Guide. Alex Dmitrienko,
Christy Chuang-Stein, Ralph D'Agostino (editors) [SAS Press, 2007]
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