Monitoring futility and efficacy in phase II trials with Bayesian posterior distributions-A calibration approach.
Bayesian design
INFORM study
calibration
futility
interim analyses
Journal
Biometrical journal. Biometrische Zeitschrift
ISSN: 1521-4036
Titre abrégé: Biom J
Pays: Germany
ID NLM: 7708048
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
25
10
2017
revised:
06
07
2018
accepted:
07
07
2018
pubmed:
4
9
2018
medline:
6
2
2020
entrez:
4
9
2018
Statut:
ppublish
Résumé
A multistage single arm phase II trial with binary endpoint is considered. Bayesian posterior probabilities are used to monitor futility in interim analyses and efficacy in the final analysis. For a beta-binomial model, decision rules based on Bayesian posterior probabilities are converted to "traditional" decision rules in terms of number of responders among patients observed so far. Analytical derivations are given for the probability of stopping for futility and for the probability to declare efficacy. A workflow is presented on how to select the parameters specifying the Bayesian design, and the operating characteristics of the design are investigated. It is outlined how the presented approach can be transferred to statistical models other than the beta-binomial model.
Identifiants
pubmed: 30175405
doi: 10.1002/bimj.201700209
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
488-502Informations de copyright
© 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.