Benefit-risk analysis: a proposal using quantitative methods
Article first published online: 15 SEP 2003
Copyright © 2003 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 12, Issue 7, pages 611–616, October/November 2003
How to Cite
Holden, W. L., Juhaeri, J. and Dai, W. (2003), Benefit-risk analysis: a proposal using quantitative methods. Pharmacoepidem. Drug Safe., 12: 611–616. doi: 10.1002/pds.887
- Issue published online: 15 SEP 2003
- Article first published online: 15 SEP 2003
- benefit-risk analysis;
- minimum clinical efficacy analysis
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. Copyright © 2003 John Wiley & Sons, Ltd.