How to ascertain drug safety in the context of benefit. Controversies and concerns.

Academic Article

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

    Published In

    Keywords

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

    Author List

  • Simon LS; Strand CV; Boers M; Brooks PM; Tugwell PS; Bombardier C; Fries JF; Henry D; Goldkind L; Guyatt G
  • Start Page

  • 2114
  • End Page

  • 2121
  • Volume

  • 36
  • Issue

  • 9