Two-stage designs for cross-over bioequivalence trials

• Verfasst von: Kieser, Meinhard [VerfasserIn]
• Verfasst von: Rauch, Geraldine [VerfasserIn]
• Titel: Two-stage designs for cross-over bioequivalence trials
• Verf.angabe: Meinhard Kieser and Geraldine Rauch
• E-Jahr: 2015
• Jahr: 24 March 2015
• Umfang: 14 S.
• Fussnoten: Gesehen am 01.07.2020
• Titel Quelle: Enthalten in: Statistics in medicine
• Ort Quelle: Chichester [u.a.] : Wiley, 1982
• Jahr Quelle: 2015
• Band/Heft Quelle: 34(2015), 16, Seite 2403-2416
• ISSN Quelle: 1097-0258
• DOI: doi:10.1002/sim.6487
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: adaptive design
• Sach-SW: bioequivalence
• Sach-SW: cross-over design
• Sach-SW: sample size recalculation
• Sach-SW: two-stage design
• K10plus-PPN: 1703023420

Abstract

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.