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

Aupiais, Camille; Alberti, Corinne; Schmitz, Thomas; Baud, Olivier; Ursino, Moreno; Zohar, Sarah

doi:10.1186/s12874-019-0826-5

Scientific article

English

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

Contributors

Aupiais, Camille; Alberti, Corinne; Schmitz, Thomas; Baud, Olivier; Ursino, Moreno; Zohar, Sarah

Published in

BMC Medical Research Methodology, vol. 19, no. 1, 187

Publication date

2019

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

UNIGE affiliation entities

Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

UNIGE research groups

Prévention des complications néonatales d'origine périnatale (990)

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

Article (Published version)

CC BY

Identifiers

PID : unige:137371
DOI : 10.1186/s12874-019-0826-5
PMID : 31533631

Additional URL for this publication

https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-019-0826-5

Datasets

https://doi.org/10.6084/m9.figshare.c.4671086.v1

Journal ISSN

1471-2288

357views

140downloads

Creation

18/06/2020 10:42:00

First validation

18/06/2020 10:42:00

Update

15/03/2023 22:09:34

Status update

15/03/2023 22:09:33

Last indexation

31/10/2024 18:59:32

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

Contributors

Published in

Publication date

Abstract

Keywords

UNIGE affiliation entities

UNIGE research groups

Citation (ISO format)

Main files (1)

Identifiers

Additional URL for this publication

Datasets

Journal ISSN

Technical informations

Creation

First validation

Update

Status update

Last indexation