Premium
Patient‐Focused Drug Development Methods for Benefit–Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs
Author(s) -
Holmes Emily A.F.,
Plumpton Catrin,
Baker Gus A.,
Jacoby Ann,
Ring Adele,
Williamson Paula,
Marson Anthony,
Hughes Dyfrig A.
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1231
Subject(s) - lamotrigine , topiramate , weighting , antiepileptic drug , preference , medicine , clinical trial , drug , epilepsy , rank (graph theory) , intensive care medicine , pharmacology , psychiatry , statistics , mathematics , combinatorics , radiology
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 ( AED s), as indicated from clinical studies, was compared with ordering based on weighting clinical evidence by patients’ preferences. A statistically significant change in rank ordering of AED s was observed for women of childbearing potential who were prescribed monotherapy for generalized or unclassified epilepsy. Rank ordering inferred from trial data, valproate > topiramate > lamotrigine, was reversed. Modeling the expected utility of drugs might address the need to use more systematic, methodologically sound approaches to collect patient input that can further inform regulatory decision making.