Drug safety in spontaneous reports, observational databases, and clinical trials: Can we do better?

TitleDrug safety in spontaneous reports, observational databases, and clinical trials: Can we do better?
Publication TypePresentation
Year of Publication2011
AuthorsMadigan, D
KeywordsSymposium I
Abstract

A number of recent high-profile drug safety issues have demonstrated our lack of understanding of the toxicities associated with marketed pharmaceutical products. This talk will review current strategies that regulators use to analyze safety, describe potential improvements, and highlight the vital role than research statisticians can play going forward.