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Bayesian sample size determination in non‐sequential clinical trials: Statistical aspects and some regulatory considerations
Author(s) -
Grouin JeanMarie,
Coste Maylis,
Bunouf Pierre,
Lecoutre Bruno
Publication year - 2007
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.2958
Subject(s) - frequentist inference , bayesian probability , sample size determination , prior probability , context (archaeology) , computer science , clinical trial , econometrics , sample (material) , drug development , bayes' theorem , relevance (law) , statistics , bayesian inference , artificial intelligence , mathematics , medicine , drug , pharmacology , paleontology , chemistry , chromatography , political science , law , biology
The most common Bayesian methods for sample size determination (SSD) are reviewed in the non‐sequential context of a confirmatory phase III trial in drug development. After recalling the regulatory viewpoint on SSD, we discuss the relevance of the various priors applied to the planning of clinical trials. We then investigate whether these Bayesian methods could compete with the usual frequentist approach to SSD and be considered as acceptable from a regulatory viewpoint. Copyright © 2007 John Wiley & Sons, Ltd.