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Patient-focused drug development methods for benefit-risk assessments : A case study using discrete choice experiment for antiepileptic drugs. / Holmes, Emily A.F.; Plumpton, Catrin; Baker, Gus A.; Jacoby, Ann; Ring, Adele ; Williamson, Paula; Marson, Anthony ; Hughes, Dyfrig A.

In: Clinical Pharmacology and Therapeutics, Vol. 105, No. 3, 03.2019, p. 672-683.

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Holmes, Emily A.F. ; Plumpton, Catrin ; Baker, Gus A. ; Jacoby, Ann ; Ring, Adele ; Williamson, Paula ; Marson, Anthony ; Hughes, Dyfrig A. / Patient-focused drug development methods for benefit-risk assessments : A case study using discrete choice experiment for antiepileptic drugs. In: Clinical Pharmacology and Therapeutics. 2019 ; Vol. 105, No. 3. pp. 672-683.

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TY - JOUR

T1 - Patient-focused drug development methods for benefit-risk assessments

T2 - Clinical Pharmacology and Therapeutics

AU - Holmes, Emily A.F.

AU - Plumpton, Catrin

AU - Baker, Gus A.

AU - Jacoby, Ann

AU - Ring, Adele

AU - Williamson, Paula

AU - Marson, Anthony

AU - Hughes, Dyfrig A.

N1 - Funded by the National Institute for Health Research (NIHR), under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0909-20161). PW, AM, DAH are also supported by the Medical Research Council North West Hub for Trials Methodology Research (NWHTMR Reference number MR/K025635/1). AM is part-funded by NIHR Collaboration for Leadership in Applied Health Research and Care North West Coast (NIHR CLAHRC NWC); and DAH is a Health and Care Research Wales Senior Research Leader (SRL/15/029).

PY - 2019/3

Y1 - 2019/3

N2 - 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.

AB - 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.

KW - Benefit-risk

KW - Regulatory Decision Making

KW - Quantitative methods

KW - Anti-epileptic drugs

U2 - 10.1002/cpt.1231

DO - 10.1002/cpt.1231

M3 - Article

VL - 105

SP - 672

EP - 683

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

SN - 0009-9236

IS - 3

ER -