title: How to ascertain drug safety in the context of benefit. Controversies and concerns.
abstract: 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.
authors.affiliation: Harvard Medical School, Boston, MA, USA. omeract@uottawa.ca
authors.forename: Lee S
authors.initials: LS
authors.lastname: Simon
authors.forename: C Vibeke
authors.initials: CV
authors.lastname: Strand
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: Peter M
authors.initials: PM
authors.lastname: Brooks
authors.forename: Peter S
authors.initials: PS
authors.lastname: Tugwell
authors.forename: Claire
authors.initials: C
authors.lastname: Bombardier
authors.forename: James F
authors.initials: JF
authors.lastname: Fries
authors.forename: David
authors.initials: D
authors.lastname: Henry
authors.forename: Larry
authors.initials: L
authors.lastname: Goldkind
authors.forename: Gordon
authors.initials: G
authors.lastname: Guyatt
authors.forename: Andreas
authors.initials: A
authors.lastname: Laupacis
authors.forename: Larry
authors.initials: L
authors.lastname: Lynd
authors.forename: Tom
authors.initials: T
authors.lastname: Macdonald
authors.forename: Muhammad
authors.initials: M
authors.lastname: Mamdani
authors.forename: Andrew
authors.initials: A
authors.lastname: Moore
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Saag
authors.forename: Ken S
authors.initials: KS
authors.lastname: Saag
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Silman
authors.forename: Randall
authors.initials: R
authors.lastname: Stevens
authors.forename: Alan
authors.initials: A
authors.lastname: Tyndall
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D035843:Biomedical Research; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D017891:Pharmacoepidemiology; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012216:Rheumatic Diseases / Q000188:drug therapy*; D018570:Risk Assessment
chemical_list: D018501:Antirheumatic Agents