Benefit-risk analysis: a proposal using quantitative methods

Pharmacoepidemiol Drug Saf. 2003 Oct-Nov;12(7):611-6. doi: 10.1002/pds.887.


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.

MeSH terms

  • Guidelines as Topic*
  • Humans
  • Pharmacoepidemiology*
  • Risk Assessment*