Quantitative evaluation of safety in drug development : design, analysis and reporting

Preface . . IX
Editors . . XI
Contributors . . XII

Section I Study Design
1. Incorporating Quantitative Safety Evaluation into Risk Management . . 3
2. Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk . . 13
3. Non-Inferiority Study Design and Analysis for Safety Endpoints . . 39 

Section II Safety Monitoring
4. Program Safety Analysis Plan: An Implementation Guide . . 55 
5. Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial . . 69
6. Safety Surveillance and Signal Detection Process . . 93 

Section III Evaluation/Analysis
7. Bayesian Adaptive Trials for Drug Safety . . 109
8. Observational Safety Study Design, Analysis, and Reporting . . 125
9. Emerging Role of Observational Health-Care Data in Pharmacovigilance . . 141
10. Roadmap for Causal Inference in Safety Analysis . . 173
11. Safety Graphics . . 195
12. Bayesian Network Meta-Analysis for Safety Evaluation . . 223
13. Regulatory Issues in Meta-Analysis of Safety Data . . 237
14. Bayesian Applications for Drug Safety Evaluation . . 251
15. Risk-Benefit Assessment Approaches . . 267
16. Detecting Safety Signals in Subgroups . . 289
17. Overview of Safety Evaluation and Quantitative Approaches during Preclinical and Early Phases of Drug Development . . 321

Index . . 339