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

著者名：Wang, William (EDT)/Munsaka, Melvin (EDT)/Buchanan, James (EDT)/Li, Judy (EDT)

Chapman and Hall/CRC（2021/12/30発売）

• 言語：ENG
• ISBN：9781138594067
• eISBN：9780429949999

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 21^st century safety evaluation.

Table of Contents

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