Table of Contents

Preface. Introduction to R. Overview of Clinical Trials. Sample Size Determination in Clinical Trials. Two Treatment Comparisons in Clinical Trials. Multi-Arm Comparisons in Clinical Trials (ANOVA). Treatment Comparisons Incorporating Covariates in Clinical Trials (ANCOVA). Clinical Trials with Time-to-Events Endpoints. Clinical Trials with Repeated Measures. Meta-Analysis in Clinical Trials. Bayesian Methods in Clinical Trials. Group Sequential Designs and Monitoring in Clinical Trials. Bioequivalence Clinical Trials. Monitoring Clinical Trials for Adverse Events.

About the Author

Ding-Geng (Din) Chen, Ph.D., is a professor at the University of Rochester Medical Center. Dr. Chen has vast experience in

biostatistical research and clinical trial development and methodology. He has authored or co-authored more than 100 journal

publications on biostatistical methodologies and applications. He is also the co-author (with Dr. Peace) of Clinical Trial Methodology

and Clinical Trial Data Analysis Using R and a co-editor (with Drs. Sun and Peace) of Interval-Censored Time-to-Event Data: Methods

and Applications. He is a member of the American Statistical Association, chair for the STAT section of the American Public Health

Association, an associate editor of the Journal of Statistical Computation and Simulation, and an editorial board member of several

other journals.

Karl E. Peace, Ph.D., is the Georgia Cancer Coalition Distinguished Cancer Scholar, senior research scientist, and professor of

biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University. He is also an adjunct professor of

biostatistics at the VCU School of Medicine. Dr. Peace is a reviewer or editor of several journals, the founding editor of the Journal of

Biopharmaceutical Statistics, and a fellow of the American Statistical Association. He has authored or co-authored over 150 articles

and 10 books. He has received numerous awards, including the University System of Georgia Board of Regents’ Alumni Hall of Fame

Award, the First President’s Medal for outstanding contributions to Georgia Southern University, and distinguished meritorious service

awards from the American Public Health Association and other organizations. In 2012, the American Statistical Association created the

Karl E. Peace Award for Outstanding Statistical Contributions for the Betterment of Society.

Reviews

" . . . this book provides a very useful overview of the statistical methods used in the analysis of clinical trials, along with their implementations. This will particularly help clinical practitioners to apply these methodologies in their own scientific problems . . . I would really like to thank the authors, D. Chen, K. E. Peace and P. Zhang, for such a nice readymade reference for clinical trial analysis, with very interesting real data illustrations."
~Abhik Ghosh, International Society for Clinical Biostatistics