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Regulatory decisions may be enhanced by incorporating patient preferences for drug benefit and harms. This study demonstrates a method of weighting clinical evidence by patients’ benefit-risk preferences. Preference weights, derived from discrete choice experiments, were applied to clinical trial data to estimate the expected utility of alternative drugs. In a case study, the rank ordering of antiepileptic drugs (AEDs) as indicated from trial data alone, was compared with ordering based on weighting clinical evidence by patients’ preferences. A statistically significant change in rank ordering of AEDs was observed for women of childbearing potential who were prescribed monotherapy for generalised or unclassified epilepsy. Rank ordering inferred from trial data, valproate > topiramate > lamotrigine, was reversed. Modelling the expected utility of drugs might address the need to utilize more systematic, methodologically-sound approaches to collect patient input that can further inform regulatory decision making.

Keywords

  • Benefit-risk, Regulatory Decision Making, Quantitative methods, Anti-epileptic drugs
Original languageEnglish
Pages (from-to)672-683
JournalClinical Pharmacology and Therapeutics
Volume105
Issue number3
Early online date11 Sep 2018
DOIs
Publication statusPublished - Mar 2019

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