4.6 Article

Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs

Journal

CLINICAL PHARMACOLOGY & THERAPEUTICS
Volume 105, Issue 3, Pages 672-683

Publisher

WILEY
DOI: 10.1002/cpt.1231

Keywords

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Funding

  1. National Institute for Health Research (NIHR) [PB-PG-0909-20161]
  2. Medical Research Council North West Hub for Trials Methodology Research [MR/K025635/1]
  3. NIHR Collaboration for Leadership in Applied Health Research and Care North West Coast
  4. National Institutes of Health Research (NIHR) [PB-PG-0909-20161] Funding Source: National Institutes of Health Research (NIHR)
  5. MRC [MR/L004933/1, MR/K025635/1, MR/L004933/2] Funding Source: UKRI

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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 clinical studies, 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 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.

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