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Keywords:

  • benefit-risk analysis;
  • pharmacoepidemiology;
  • methods;
  • number-needed-to-treat;
  • number-needed-to-harm;
  • minimum clinical efficacy analysis

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.