Two-stage designs for cross-over bioequivalence trials

Meinhard Kieser; Geraldine Rauch

doi:10.1002/sim.6487

Two-stage designs for cross-over bioequivalence trials

Standard

Two-stage designs for cross-over bioequivalence trials. / Kieser, Meinhard; Rauch, Geraldine.

in: STAT MED, Jahrgang 34, Nr. 16, 20.07.2015, S. 2403-2416.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Kieser, M & Rauch, G 2015, 'Two-stage designs for cross-over bioequivalence trials', STAT MED, Jg. 34, Nr. 16, S. 2403-2416. https://doi.org/10.1002/sim.6487

APA

Kieser, M., & Rauch, G. (2015). Two-stage designs for cross-over bioequivalence trials. STAT MED, 34(16), 2403-2416. https://doi.org/10.1002/sim.6487

Vancouver

Kieser M, Rauch G. Two-stage designs for cross-over bioequivalence trials. STAT MED. 2015 Jul 20;34(16):2403-2416. https://doi.org/10.1002/sim.6487

Bibtex

@article{c31e879fe8304804912c3e2a22b4f904,

title = "Two-stage designs for cross-over bioequivalence trials",

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.",

keywords = "Biostatistics, Computer Simulation, Cross-Over Studies, Delayed-Action Preparations, Humans, Models, Statistical, Randomized Controlled Trials as Topic, Research Design, Sample Size, Theophylline, Therapeutic Equivalency, Journal Article",

author = "Meinhard Kieser and Geraldine Rauch",

note = "Copyright {\textcopyright} 2015 John Wiley & Sons, Ltd.",

year = "2015",

month = jul,

day = "20",

doi = "10.1002/sim.6487",

language = "English",

volume = "34",

pages = "2403--2416",

journal = "STAT MED",

issn = "0277-6715",

publisher = "John Wiley and Sons Ltd",

number = "16",

}

RIS

TY - JOUR

T1 - Two-stage designs for cross-over bioequivalence trials

AU - Kieser, Meinhard

AU - Rauch, Geraldine

PY - 2015/7/20

Y1 - 2015/7/20

N2 - 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.

AB - 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.

KW - Biostatistics

KW - Computer Simulation

KW - Cross-Over Studies

KW - Delayed-Action Preparations

KW - Humans

KW - Models, Statistical

KW - Randomized Controlled Trials as Topic

KW - Research Design

KW - Sample Size

KW - Theophylline

KW - Therapeutic Equivalency

KW - Journal Article

U2 - 10.1002/sim.6487

DO - 10.1002/sim.6487

M3 - SCORING: Journal article

C2 - 25809815

VL - 34

SP - 2403

EP - 2416

JO - STAT MED

JF - STAT MED

SN - 0277-6715

IS - 16

ER -