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

Holmes, Emily AF, Plumpton, Catrin, Baker, Gus A, Jacoby, Ann, Ring, Adele, Williamson, Paula ORCID: 0000-0001-9802-6636, Marson, Anthony ORCID: 0000-0002-6861-8806 and Hughes, Dyfrig A ORCID: 0000-0001-8247-7459 (2019) Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs. CLINICAL PHARMACOLOGY & THERAPEUTICS, 105 (3). pp. 672-683.

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Official URL: http://dx.doi.org/10.1002/cpt.1231

Abstract

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.

Item Type:	Article
Uncontrolled Keywords:	Humans, Seizures, Anticonvulsants, Focus Groups, Risk Assessment, Qualitative Research, Adolescent, Adult, Aged, Middle Aged, Patient-Centered Care, Female, Male, Young Adult, Drug Development
Depositing User:	Symplectic Admin
Date Deposited:	31 Oct 2018 11:27
Last Modified:	19 Jan 2023 01:13
DOI:	10.1002/cpt.1231
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3028183