Quantitative Drug Safety and Benefit Risk Evaluation : Practical and Cross-Disciplinary Approaches book cover
1st Edition

Quantitative Drug Safety and Benefit Risk Evaluation
Practical and Cross-Disciplinary Approaches

ISBN 9781138594067
Published December 31, 2021 by Chapman & Hall
402 Pages 33 B/W Illustrations

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Book Description

Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks.

Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.

Table of Contents

 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

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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 Group


Dr. 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.