How to ascertain drug safety in the context of benefit. Controversies and concerns

Lee S. Simon, C. Vibeke Strand, Maarten Boers, Peter M. Brooks, Peter S. Tugwell, Claire Bombardier, James F. Fries, David Henry, Larry Goldkind, Gordon H Guyatt, Andreas Laupacis, Larry Lynd, Tom MacDonald, Muhammad Mamdani, Andrew Moore, Ken S. Saag, Alan J. Silman, Randall Stevens, Alan Tyndall

Research output: Contribution to journalArticleResearchpeer-review

7 Citations (Scopus)


There is great concern about clearly defining benefit and risk in the context of both drug development and clinical practice. In view of this pressure, the OMERACT Executive identified the need to bring together clinical trialists, pharmacoepidemiologists, clinicians, clinical epidemiologists, statistical experts, and regulatory representatives to discuss different approaches to define risk and perhaps improved ways to express it. Each attendee spoke on a given topic and the group was charged to consider the issue of risk in the context of formally posed questions. This article provides a summary of the presentations and outlines the discussions that followed. The Journal of Rheumatology

Original languageEnglish
Pages (from-to)2114-2121
Number of pages8
JournalJournal of Rheumatology
Issue number9
Publication statusPublished - Sept 2009
Externally publishedYes


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