PT  - JOURNAL ARTICLE
AU  - LEE S. SIMON
AU  - C. VIBEKE STRAND
AU  - MAARTEN BOERS
AU  - PETER M. BROOKS
AU  - PETER S. TUGWELL
AU  - CLAIRE BOMBARDIER
AU  - JAMES F. FRIES
AU  - DAVID HENRY
AU  - LARRY GOLDKIND
AU  - GORDON GUYATT
AU  - ANDREAS LAUPACIS
AU  - LARRY LYND
AU  - TOM MacDONALD
AU  - MUHAMMAD MAMDANI
AU  - ANDREW MOORE
AU  - KEN S. SAAG
AU  - ALAN J. SILMAN
AU  - RANDALL STEVENS
AU  - ALAN TYNDALL
TI  - How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns
AID  - 10.3899/jrheum.090591
DP  - 2009 Sep 01
TA  - The Journal of Rheumatology
PG  - 2114--2121
VI  - 36
IP  - 9
4099  - http://www.jrheum.org/content/36/9/2114.short
4100  - http://www.jrheum.org/content/36/9/2114.full
SO  - J Rheumatol2009 Sep 01; 36
AB  - 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.