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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.

Original publication

DOI

10.3899/jrheum.090591

Type

Conference paper

Publication Date

09/2009

Volume

36

Pages

2114 - 2121

Addresses

Harvard Medical School, Boston, MA, USA. omeract@uottawa.ca

Keywords

Humans, Rheumatic Diseases, Antirheumatic Agents, Registries, Risk Assessment, Product Surveillance, Postmarketing, Pharmacoepidemiology, Biomedical Research, Randomized Controlled Trials as Topic, Drug-Related Side Effects and Adverse Reactions