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A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis

Tervonen, T., van Valkenhoef, G., Buskens, E., Hillege, H. L. & Postmus, D., 30-May-2011, In : Statistics in Medicine. 30, 12, p. 1419-1428 10 p.

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Drug benefit-risk (BR) analysis is based on firm clinical evidence regarding various safety and efficacy outcomes. In this paper, we propose a new and more formal approach for constructing a supporting multicriteria model that fully takes into account the evidence on efficacy and adverse drug reactions. Our approach is based on the stochastic multi-criteria acceptability analysis methodology, which allows us to compute the typical value judgments that support a decision, to quantify decision uncertainty, and to compute a comprehensive BR profile. We construct a multi-criteria model for the therapeutic group of second-generation antidepressants. We assess fluoxetine and venlafaxine together with placebo according to incidence of treatment response and three common adverse drug reactions by using data from a published study. Our model shows that there are clear trade-offs among the treatment alternatives. Copyright (C) 2011 John Wiley & Sons, Ltd.

Original languageEnglish
Pages (from-to)1419-1428
Number of pages10
JournalStatistics in Medicine
Volume30
Issue number12
Publication statusPublished - 30-May-2011

    Keywords

  • clinical pharmacology, decision analysis, benefit-risk analysis, stochastic multi-criteria acceptability analysis (SMAA), ACCEPTABILITY ANALYSIS, ORDINAL CRITERIA, ALTERNATIVES, MANAGEMENT, TRIALS, SMAA-2

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