Performance of adaptive designs for single-armed phase II oncology trials
When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to speci...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
15 Apr 2015
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| In: |
Journal of biopharmaceutical statistics
Year: 2015, Volume: 25, Issue: 3, Pages: 602-615 |
| ISSN: | 1520-5711 |
| DOI: | 10.1080/10543406.2014.920863 |
| Online Access: | Resolving-System, lizenzpflichtig, Volltext: https://doi.org/10.1080/10543406.2014.920863 Verlag, lizenzpflichtig, Volltext: https://www.tandfonline.com/doi/full/10.1080/10543406.2014.920863 
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| Author Notes: | Meinhard Kieser and Stefan Englert |
| Summary: | When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to specify an interval for the possible true rate to accommodate this uncertainty. For this situation, we examine comprehensively the overall performance of various Phase II oncology designs and sample size recalculation strategies. The methods and results of our investigations can be used to identify the most appropriate approach for a specific clinical trial situation at hand. Application is illustrated with a clinical trial in rectal cancer. |
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| Item Description: | Accepted author version posted online: 06 Jun 2014 Gesehen am 01.07.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1520-5711 |
| DOI: | 10.1080/10543406.2014.920863 |