How to ascertain drug safety in the context of benefit. Controversies and concerns.
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.
Simon
Lee S
LS
Harvard Medical School, Boston, MA, USA. omeract@uottawa.ca
Strand
C Vibeke
CV
Boers
Maarten
M
Brooks
Peter M
PM
Tugwell
Peter S
PS
Bombardier
Claire
C
Fries
James F
JF
Henry
David
D
Goldkind
Larry
L
Guyatt
Gordon
G
Laupacis
Andreas
A
Lynd
Larry
L
Macdonald
Tom
T
Mamdani
Muhammad
M
Moore
Andrew
A
Saag
Kenneth G
KG
Saag
Ken S
KS
Silman
Alan J
AJ
Stevens
Randall
R
Tyndall
Alan
A
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
D018501:Antirheumatic Agents