Point estimation and p-values in phase II adaptive two-stage designs with a binary endpoint
Clinical trials in phase II of drug development are frequently conducted as single-arm two-stage studies with a binary endpoint. Recently, adaptive designs have been proposed for this setting that enable a midcourse modification of the sample size. While these designs are elaborated with respect to...
Gespeichert in:
| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
15 March 2017
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| In: |
Statistics in medicine
Year: 2017, Jahrgang: 36, Heft: 6, Pages: 971-984 |
| ISSN: | 1097-0258 |
| DOI: | 10.1002/sim.7200 |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1002/sim.7200 Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.7200 
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| Verfasserangaben: | K. Kunzmann and M. Kieser |
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| 520 | |a Clinical trials in phase II of drug development are frequently conducted as single-arm two-stage studies with a binary endpoint. Recently, adaptive designs have been proposed for this setting that enable a midcourse modification of the sample size. While these designs are elaborated with respect to hypothesis testing by assuring control of the type I error rate, the topic of point estimation has up to now not been addressed. For adaptive designs with a prespecified sample size recalculation rule, we propose a new point estimator that both assures compatibility of estimation and test decision and minimizes average mean squared error. This estimator can be interpreted as a constrained posterior mean estimate based on the non-informative Jeffreys prior. A comparative investigation of the operating characteristics demonstrates the favorable properties of the proposed approach. Copyright © 2016 John Wiley & Sons, Ltd. | ||
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