Statistical Issues in Drug Development - (Statistics in Practice) 3rd Edition by Stephen S Senn (Hardcover)

About the Book

"This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard. This book is unique in providing a thorough and critical discussion of the most important and controversial issues encountered by statisticians and their life scientist colleagues on both sides of the regulatory divide in drug development. The primary purpose of the book is to encourage and facilitate discussion between statisticians and their colleagues of the many complex statistical issues that arise in drug development. The book will be suitable as a course of self-instruction for statisticians who are new to the pharmaceutical industry, either because of recent graduation or change of career. It will also act as an authoritative reference for those working in drug development, and provide possible topics for discussion in journal forums"--

Book Synopsis

Statistical Issues in Drug Development

The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more.

This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of:

• A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development
• An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional
• An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects

Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

From the Back Cover

The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more.

This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of:

• A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development
• An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional
• An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects

Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

About the Author

Professor Stephen Senn (MSc, PhD, CStat) is a statistical consultant, researcher and blogger. He has extensive experience in both academia and industry, and is recognized worldwide for his studies in statistical methodology applied to drug development.

Professor Senn has been the recipient of national and international awards, including the 1st George C Challis award for Biostatistics at the University of Florida, and the Bradford Hill Medal of the Royal Statistical Society. He is a Fellow of the Royal Society of Edinburgh and an honorary life member of Statisticians in the Pharmaceutical Industry (PSI) and the International Society for Clinical Biostatistics (ISCB) and has honorary professorships in statistics at The University of Sheffield and the University of Edinburgh.