Quantitative Evaluation of Safety in Drug Development ― Design, Analysis and Reporting

Drug safety has always been important, but it’s taken on increasing criticality and scrutiny in recent years. This book covers the most state-of-the-art methods in drug safety assessment. In addition, statistical methods for drug safety assessment are still evolving and new methods are under development. This book is designed to bring the most-advanced knowledge and statistical methodology to the statistical/clinical/safety community, share best practices, and stimulate further research and methodology development in the drug safety area.

Qi Jiang, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Jiang is a fellow of the American Statistical Association, a member of many industry-wide initiatives, and an associate editor of the journal Statistics in Biopharmaceutical Research (SBR). She has over 18 years of clinical trial experience in early and late clinical development phases across a broad spectrum of therapeutic areas. Her research interests include drug safety monitoring and analyses, benefit-risk assessment, clinical meaningfulness, dichotomization, meta-analyses, network meta-analysis, adaptive design, and non-inferiority study design and analyses.

H. Amy Xia, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Xia is a member of many industry-wide initiatives. In the past 18 years, she has worked on designing, executing, and reporting clinical trials as well as observational studies for developing pharmaceutical and medical device products in a wide range of different disease areas. Her research interests include safety biostatistics, signal detection, Bayesian design, monitoring and analysis of clinical trials, meta-analysis, and adaptive design.