Benefit-risk analysis: a proposal using quantitative methods.
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.
Holden
William L
WL
Aventis Pharmaceuticals, Bridgewater, NJ, USA. William.Holden@aventis.com
Juhaeri
Juhaeri
J
Dai
Wanju
W
D017408:Guidelines as Topic; D006801:Humans; D017891:Pharmacoepidemiology; D018570:Risk Assessment