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Pharmacoepidemiol Drug Saf. 2003 Oct-Nov;12(7):611-6.

Benefit-risk analysis: a proposal using quantitative methods.

Author information

1
Aventis Pharmaceuticals, Bridgewater, NJ, USA. William.Holden@aventis.com

Abstract

This is the first part of a two-article series which will introduce the theory and practice of a proposed set of quantitative methods for benefit-risk analysis. Adjustments to number-needed-to-treat (NNT) analysis and a new method, minimum clinical efficacy (MCE) analysis are presented and critically discussed. The goal of these methods is to condense into a summary metric the benefit-risk profile of a product so that manufacturers, regulators, clinicians and patients can better understand and participate in risk management. A second article will present examples of these methods.

PMID:
14558185
DOI:
10.1002/pds.887
[Indexed for MEDLINE]

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