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Interview with the Authors of New Clinical Trials Book

Authorline interviews Alex Dmitrienko, Walter Offen, and Christy Chuang-Stein, authors of Analysis of Clinical Trials Using SAS: A Practical Guide. This book will be available in the fall of 2004. Geert Molenbergs was not available for comment.

Authorline (AL): What was your motivation for writing your book?
Alex Dmitrienko (AD): Most existing books on statistical issues arising in clinical trials focus on statistical theory and are not for the faint of heart. Very few books discuss implementation of the statistical methods and their applications to real-life problems. We wanted to write a book for practitioners. The idea was to review popular statistical methods, present practical advice from experts and explain how to implement the methods in SAS.
(AL): Who are you targeting with your book?
(AD): The book was written for statisticians and other scientists in the pharmaceutical and biotechnology industry, academic institutions and various branches of Federal government (e.g., Food and Drug Administration and the National Institutes of Health). The book can also be used as a text for graduate programs in biostatistics.
(AL): What features of the book are you especially pleased with?
(AD): The book provides a gentle introduction to complex problems arising in the world of clinical trials and is accessible to readers who are new to the game. At the same time, we have included numerous tidbits for more experienced statisticians and SAS users.
(AL): How will your book benefit SAS users?
(AD): To the best of our knowledge, this is the first book that reviews the most important problems statisticians and other SAS users encounter in clinical trials (analysis of stratified data, multiple tests, interim analyses and analysis of incomplete data) and teaches them how to get results in SAS. We like to think of it as one-stop shopping.
(AL): What were some of the joys of writing this book?
(AD): I worked with a team of very talented people and I got to be the boss! Also, I liked receiving the most current versions of various SAS products. When you work in a highly regulated industry (pharmaceutical industry), you are always two versions behind.
Christy Chuang-Stein (CCS): An additional source of gratification is the knowledge that the book will help promote the use of modern statistical methodology because of the availability of programs to implement them in the familiar SAS computing environment.
Walter Offen (WO): Working with the other authors and reviewers who are some of the top statistical experts.
(AL): How did you develop as a writer while you were creating this book?
(AD): I quickly realized that the most difficult part of writing a book is writing succinctly and to the point. I went through 25 revisions with my first chapter and had to compress it from 120 pages to 70 pages. I think I became a more efficient writer by the time I got to my last chapter.
(AL): How did you decide to publish with SAS?
(AD): This was an easy decision since we were thinking about writing a book for biostatisticians and other professionals who work with clinical trial data. Most of them use SAS software and read SAS books.
(AL): Are you glad you decided to publish with SAS? If so, what has made the experience a good one?
(AD): We certainly are. It is great to work with a team of dedicated and enthusiastic people. Can we use this opportunity to thank Donna Faircloth, our editor at SAS Books by Users Press? She has helped us put this complex puzzle together.
(AL): Your book will be going to the printer in just a few weeks. How does it feel to be in the home stretch of such a long project?
(AD): I can finally see the light at the end of this long tunnel (the first outline of the book was put together the day before the tragic events of September 11, 2001).
(AL): What advice would you give to potential authors?
(AD): I think the more time you spend upfront planning and thinking about the structure of the book the better. Plus, contact the thought leaders in your area and ask them to review your work. Each chapter in this book has been read by at least five people. We received a lot of valuable feedback.
(CCS): Have a realistic estimate on how much time a book project could take.
(AL): How were you able to balance your time between your career and writing this book?
(AD): I did close to 75% of my contribution during the first year of my son's life (he is two now). He was not a good sleeper and, at some points, the difference between day and night was completely blurred. I clearly did not have time for advancing my career, and I decided to focus on the book instead.
(CCS): We did spend personal time to work on the book project. However, publishing is part of the career development for all the authors of this book.
(WO): Timelines for the book were long enough to fit it in.
(AL): When you aren't writing or consulting, how do you like to spend your free time?
(AD): I like to travel with my family and play with my kids. I have recently become a telecommuter and, to be honest, this was just an excuse to spend more time with my family!
(WO): Reading, investing, spending time with family.
(AL): How did you decide to co-author the book? How did you divide your responsibilities?
(CCS): The leading author served as the champion for the book, coordinating the responsibilities among the co-authors and serving as the primary contact with SAS. It is important for any joint project to have a leader who acts like a project manager. In our case, the leading author not only serves as the project manager, but also is the leading contributor on the technical contents of the book.

Alex Dmitrienko	Alex Dmitrienko, Ph.D., Principal Research Scientist, Eli Lilly and Company, 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. His other interests include software implementation of new and existing statistical methods.	Walter Offen	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	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 Molenbergs	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.

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Interview with the Authors of New Clinical Trials Book