Benefit‐risk analysis: a proposal using quantitative methods

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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. Copyright © 2003 John Wiley & Sons, Ltd.