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Benefit‐risk analysis: a proposal using quantitative methods
Author(s) -
Holden William L.,
Juhaeri Juhaeri,
Dai Wanju
Publication year - 2003
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.887
Subject(s) - medicine , risk analysis (engineering) , metric (unit) , number needed to treat , risk management , set (abstract data type) , intensive care medicine , actuarial science , operations management , computer science , relative risk , confidence interval , engineering , business , management , economics , programming language
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.