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Two‐stage designs for cross‐over bioequivalence trials
Author(s) -
Kieser Meinhard,
Rauch Geraldine
Publication year - 2015
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.6487
Subject(s) - bioequivalence , sample size determination , computer science , adaptive design , sequential analysis , clinical study design , field (mathematics) , sample (material) , design of experiments , management science , statistics , clinical trial , mathematics , medicine , engineering , chemistry , pathology , chromatography , pure mathematics , pharmacology , bioavailability
The topic of applying two‐stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non‐inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid‐course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd.