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