Fundamental Concepts for New Clinical Trialists

Dr. Scott Evans teaches clinical trials at Harvard University, where he is the director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group, an NIH-funded clinical trials network. He serves on a U.S. FDA Advisory Committee and several data monitoring committees for industry and NIH-sponsored clinical trials. He has been a recipient of the Mosteller Statistician of the Year Award and is a fellow of the American Statistical Association. Dr. Evans is a visiting professor at the Department of Medical Statistics at Osaka University and serves as the executive editor for CHANCE and the editor-in-chief of Statistical Communications in Infectious Diseases.Dr. Naitee Ting has close to 30 years of experience in the pharmaceutical industry and currently works at Boehringer Ingelheim. He has also taught courses on clinical trials in the Department of Statistics at the University of Connecticut, University of Rhode Island, and Department of Biostatistics at Columbia University. He is a fellow of the American Statistical Association.

"The book focuses on important concepts and promotes ‘thinking clinical trials’, and it is very readable. This book targets both statisticians and non-statisticians and wishes to facilitate better communication between them. I found that some chapters are especially useful for statisticians involved in clinical trials. . . Dr Evans uses this book as part of his ‘Principles of Clinical Trials’ course at the Harvard School of Public Health. Overall, it is an exciting book!"~International Statistical Review"Statisticians learn the easy part of designing and analyzing clinical trials in class, but we usually learn the hard parts by our post-graduate failures. This book offers a course outline and valuable set of instructions to describe how to avoid many lessons we might otherwise have to learn the hard way." ~The International Biometric Society

• Background: Clinical Trials. Product Development Process. Regulatory Review Organizations. Clinical Trial Statisticians. Scientific and Practical Issues: General Considerations in Clinical Trial Design. Clinical Trial Designs. Interim Data Monitoring. Analysis Considerations. Analysis of Safety, Benefit:Risk, and Quality of Life. Publishing Trial Results. Appendix. Index.