RT Journal Article
SR Electronic
T1 How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2114
OP 2121
DO 10.3899/jrheum.090591
VO 36
IS 9
A1 LEE S. SIMON
A1 C. VIBEKE STRAND
A1 MAARTEN BOERS
A1 PETER M. BROOKS
A1 PETER S. TUGWELL
A1 CLAIRE BOMBARDIER
A1 JAMES F. FRIES
A1 DAVID HENRY
A1 LARRY GOLDKIND
A1 GORDON GUYATT
A1 ANDREAS LAUPACIS
A1 LARRY LYND
A1 TOM MacDONALD
A1 MUHAMMAD MAMDANI
A1 ANDREW MOORE
A1 KEN S. SAAG
A1 ALAN J. SILMAN
A1 RANDALL STEVENS
A1 ALAN TYNDALL
YR 2009
UL http://www.jrheum.org/content/36/9/2114.abstract
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.