Quantitative Evaluation of Safety in Drug Development : Design, Analysis and Reporting book cover
1st Edition

Quantitative Evaluation of Safety in Drug Development
Design, Analysis and Reporting

ISBN 9781466555457
Published December 8, 2014 by Chapman and Hall/CRC
382 Pages - 44 B/W Illustrations

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Book Description

State-of-the-Art Methods for Drug Safety Assessment

Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.

The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation.

Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Table of Contents

Study Design
Incorporating Quantitative Safety Evaluation into Risk Management Jürgen Kübler

Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk Joseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu, and Violeta Hennessey

Non-Inferiority Study Design and Analysis for Safety Endpoints Steven Snapinn and Qi Jiang

Safety Monitoring
Program Safety Analysis Plan: An Implementation Guide Brenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, and Qi Jiang

Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial

Mark Schactman and Janet Wittes

Safety Surveillance and Signal Detection Process Atsuko Shibata and José M. Vega

Bayesian Adaptive Trials for Drug Safety Jason T. Connor

Observational Safety Study Design, Analysis, and Reporting Hong Qiu, Jesse A. Berlin, and Paul E. Stang

Emerging Role of Observational Health-Care Data in Pharmacovigilance Patrick Ryan, David Madigan, and Martijn Schuemie

Roadmap for Causal Inference in Safety Analysis Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der Laan

Safety Graphics Susan P. Duke, Qi Jiang, Liping Huang, Mary Banach, and Max Cherny

Bayesian Network Meta-Analysis for Safety Evaluation Bradley P. Carlin and Hwanhee Hong

Regulatory Issues in Meta-Analysis of Safety Data Aloka G. Chakravarty and Mark Levenson

Bayesian Applications for Drug Safety Evaluation H. Amy Xia and Karen L. Price

Risk-Benefit Assessment Approaches Chunlei Ke, Qi Jiang, and Steven Snapinn

Detecting Safety Signals in Subgroups Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama, and Kazuhiko Kuribayashi

Overview of Safety Evaluation and Quantitative Approaches during Preclinical and Early Phases of Drug Development John Sullivan and Hisham Hamadeh


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Qi Jiang, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Jiang is a fellow of the American Statistical Association, a member of many industry-wide initiatives, and an associate editor of the journal Statistics in Biopharmaceutical Research (SBR). She has over 18 years of clinical trial experience in early and late clinical development phases across a broad spectrum of therapeutic areas. Her research interests include drug safety monitoring and analyses, benefit-risk assessment, clinical meaningfulness, dichotomization, meta-analyses, network meta-analysis, adaptive design, and non-inferiority study design and analyses.

H. Amy Xia, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Xia is a member of many industry-wide initiatives. In the past 18 years, she has worked on designing, executing, and reporting clinical trials as well as observational studies for developing pharmaceutical and medical device products in a wide range of different disease areas. Her research interests include safety biostatistics, signal detection, Bayesian design, monitoring and analysis of clinical trials, meta-analysis, and adaptive design.