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