Scientific article
OA Policy
English

A Bayesian non-inferiority approach using experts' margin elicitation - application to the monitoring of safety events

Published inBMC Medical Research Methodology, vol. 19, no. 1, 187
Publication date2019
Abstract

When conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the trial. Bayesian non-inferiority approaches have been developed, but commonly utilize historical placebo-controlled data to define the margin, depend on a single final analysis, and no recommendation is provided to define the prespecified decision threshold. In this study, we propose a non-inferiority Bayesian approach for sequential monitoring of rare dichotomous safety events incorporating experts' opinions on margins.

Keywords
  • Clinical trial
  • Non-inferiority
  • Bayesian inference
  • Mixture model
  • Children
  • Elicitation
Citation (ISO format)
AUPIAIS, Camille et al. A Bayesian non-inferiority approach using experts” margin elicitation - application to the monitoring of safety events. In: BMC Medical Research Methodology, 2019, vol. 19, n° 1, p. 187. doi: 10.1186/s12874-019-0826-5
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Article (Published version)
Identifiers
Journal ISSN1471-2288
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131downloads

Technical informations

Creation18/06/2020 10:42:00
First validation18/06/2020 10:42:00
Update15/03/2023 22:09:34
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