Quantitative Drug Safety and Benefit Risk Evaluation

Dr. William (Bill) Wang is currently Executive Director in the department of Biostatistics and Research Decision Sciences, Merck Research Laboratories, where he has worked for 20+ years. Bill has served as the deputy topics-leader for the ICH E17 Working Group and has co-chaired the ASA Biopharmaceutical Safety Working Group. He is an elected ASA Fellow.Dr. Melvin S. Munsaka is currently Senior Director and Head of Safety Statistics at AbbVie. He has more than 25 years of industry experience. He is a member of the ASA Biopharmaceutical Safety Scientific Working Group, DIA Bayesian Scientific Working Group, and the PHUSE Safety Analytics Working GroupDr. James Buchanan, president of Covilance LLC, has 30+ years of drug safety experience in the pharmaceutical industry. He is a co-lead of the ASA Biopharmaceutical Safety Working Group and the Interactive Safety Graphics taskforce that is developing novel, open-source, interactive graphical tools to evaluate drug safety issues.Dr. Judy X. Li is currently Senior Director, Biostatistics Lead for San Diego site Bristol Myers Squibb. She also has extensive experience working at the US Food and Drug Administration as a master statistical reviewer and supervisory mathematical statistician. She is the founding co-chair of the ASA Biopharmaceutical Safety Working Group.

"This is an amazing book for anyone working in the clinical research industry and does not require at all extensive knowledge of statistics or prior exposure to statistics at all. In fact, I would say that the target audience is broader than just statisticians but including instead everyone working in the clinical research industry involved in study planning, analysis and/or reporting." - David Manteigas, ISCB News, September 2022."Overall, this book provides thorough background andknowledge about clinical considerations and regulatory policies, as well as a comprehensive review of frequently used safety-specific statistical methods with clear and thoughtful explanations... Therefore, I strongly recommend this book to all who eithe ralready work on clinical studies or who are new to the area and are interested in clinical trial planning and analyses."- Huan Wang, The American Statistician, January 2023.

• 1 The Emergence of Aggregate Safety Assessment Across the Regulatory Landscape 2 Aggregate Safety Assessment Planning in Clinical Development 3 Safety Signaling and Causal Evaluation 4 Safety Monitoring through External Committees 5 An Overview on Statistical Methodologies for Safety Monitoring and Benefit-Risk Assessment 6 Quantitative Methods for Blinded Safety Monitoring 7 Bayesian Safety Methodology 8 Likelihood-Based Methods for Safety Monitoring 9 Meta-Analysis for Drug Safety Assessment 10 Design consideration for pragmatic trials with insight from cardiovascular outcome trials 11 Post-market Safety Assessment Using Observational Studies and the FDA Sentinel System 12 Analysis Considerations for Real-World Evidence and Clinical Trials Related to Safety 13 Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices 14 Estimands in Safety and Benefit Risk Evaluation 15 Visual Analytics for Safety and Benefit Risk Evaluation