JSM 2005 - Toronto

Abstract #304538

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 315
Type: Topic Contributed
Date/Time: Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304538
Title: Benefit to Risk: Why, What, and How?
Author(s): Christy Chuang-Stein*+
Companies: Pfizer, Inc.
Address: 2800 Plymouth Road, Ann Arbor, MI, 48105, United States
Keywords: benefit to risk ratio ; Side effect
Abstract:

Interventions are given with the hope to cure, or control, existing diseases or to palliate discomfort and pain. Along with the benefits that an intervention is expected to achieve, there also is the danger that the intervention would cause harm or injury. It is long recognized that all medications have risk (side effects) and that the risk associated with a medication should be evaluated with respect to its achievable benefit. In addition, the benefit-to-risk assessment should be conducted with respect to the underlying disease or symptom. There have been various attempts to quantify this tradeoff, ranging from a vague concept of benefit to risk ratio to a more elaborate quantitative construct. In this presentation, we will cover points to consider when conducting benefit to risk assessment and discuss recent approaches to carry out such assessment.


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Revised March 2005