Improving the flexibility and efficiency of phase II designs for oncology trials
Phase II trials in oncology are usually conducted as single-arm two-stage designs with binary endpoints. Currently available adaptive design methods are tailored to comparative studies with continuous test statistics. Direct transfer of these methods to discrete test statistics results in conservati...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
September 2012
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| In: |
Biometrics
Year: 2012, Volume: 68, Issue: 3, Pages: 886-892 |
| ISSN: | 1541-0420 |
| DOI: | 10.1111/j.1541-0420.2011.01720.x |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1111/j.1541-0420.2011.01720.x Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1541-0420.2011.01720.x 
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| Author Notes: | Stefan Englert and Meinhard Kieser |
| Summary: | Phase II trials in oncology are usually conducted as single-arm two-stage designs with binary endpoints. Currently available adaptive design methods are tailored to comparative studies with continuous test statistics. Direct transfer of these methods to discrete test statistics results in conservative procedures and, therefore, in a loss in power. We propose a method based on the conditional error function principle that directly accounts for the discreteness of the outcome. It is shown how application of the method can be used to construct new phase II designs that are more efficient as compared to currently applied designs and that allow flexible mid-course design modifications. The proposed method is illustrated with a variety of frequently used phase II designs. |
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| Item Description: | First published: 07 December 2011 Gesehen am 08.11.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1541-0420 |
| DOI: | 10.1111/j.1541-0420.2011.01720.x |