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Status: Bibliographieeintrag

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Verfasst von:Götte, Heiko [VerfasserIn]   i
 Schüler, Armin [VerfasserIn]   i
 Kirchner, Marietta [VerfasserIn]   i
 Kieser, Meinhard [VerfasserIn]   i
Titel:Sample size planning for phase II trials based on success probabilities for phase III
Verf.angabe:Heiko Götte, Armin Schüler, Marietta Kirchner, and Meinhard Kieser
E-Jahr:2015
Jahr:28 September 2015
Umfang:10 S.
Fussnoten:Gesehen am 31.08.2020
Titel Quelle:Enthalten in: Pharmaceutical statistics
Ort Quelle:New York, NY : Wiley, 2002
Jahr Quelle:2015
Band/Heft Quelle:14(2015), 6, Seite 515-524
ISSN Quelle:1539-1612
Abstract:In recent years, high failure rates in phase III trials were observed. One of the main reasons is overoptimistic assumptions for the planning of phase III resulting from limited phase II information and/or unawareness of realistic success probabilities. We present an approach for planning a phase II trial in a time-to-event setting that considers the whole phase II/III clinical development programme. We derive stopping boundaries after phase II that minimise the number of events under side conditions for the conditional probabilities of correct go/no-go decision after phase II as well as the conditional success probabilities for phase III. In addition, we give general recommendations for the choice of phase II sample size. Our simulations show that unconditional probabilities of go/no-go decision as well as the unconditional success probabilities for phase III are influenced by the number of events observed in phase II. However, choosing more than 150 events in phase II seems not necessary as the impact on these probabilities then becomes quite small. We recommend considering aspects like the number of compounds in phase II and the resources available when determining the sample size. The lower the number of compounds and the lower the resources are for phase III, the higher the investment for phase II should be. Copyright © 2015 John Wiley & Sons, Ltd.
DOI:doi:10.1002/pst.1717
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1002/pst.1717
 Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/pst.1717
 DOI: https://doi.org/10.1002/pst.1717
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:drug development programme
 phase II trials
 probability of success
 sample size
 time-to-event analysis
K10plus-PPN:1728067030
Verknüpfungen:→ Zeitschrift

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