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

ISBN-13: 9781138594067 / Angielski / Twarda / 2021 / 382 str.

William Wang; Melvin Munsaka; James Buchanan

Opis

This book 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.

Recenzje

"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.

Spis treści

 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