"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."-- Provided by publisher.

The emergence of aggregate safety assessment across the regulatory landscape -- Aggregate safety assessment planning in clinical development -- Safety signalling and causal evaluation -- Safety monitoring through external committees -- An overview on statistical methodologies for safety monitoring and benefit-risk assessment -- Quantitative methods for blinded safety monitoring -- Bayesian safety methodology -- Likelihood-based methods for safety monitoring -- Meta-analysis for drug safety assessment -- Design consideration for pragmatic trials with insight from cardiovascular outcome trials -- Post-market safety assessment using observational studies and the FDA Sentinel system -- Analysis considerations for real-world evidence and clinical trials related to safety -- Trends and recent progress in benefit-risk assessment planning for medical products and devices -- Estimands in safety and benefit risk evaluation -- Visual analytics for safety and benefit risk evaluation.