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Blinded sample size reestimation in non-inferiority trials with binary endpoints
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Friede, Tim, Mitchell, Charles and Mueller-Velten, Guenther. (2007) Blinded sample size reestimation in non-inferiority trials with binary endpoints. Biometrical Journal, Vol.49 (No.6). pp. 903-916. ISSN 0323-3847
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Official URL: http://dx.doi.org/10.1002/bimj.200610373
Abstract
Sample size calculations in the planning of clinical trials depend on good estimates of the model parameters involved. When the estimates of these parameters have a high degree of uncertainty attached to them, it is advantageous to reestimate the sample size after an internal pilot study. For non-inferiority trials with binary outcome we compare the performance of Type I error rate and power between fixed-size designs and designs with sample size reestimation. The latter design shows itself to be effective in correcting sample size and power of the tests when misspecification of nuisance parameters occurs with the former design.
| Item Type: | Journal Article |
|---|---|
| Subjects: | Q Science > QH Natural history > QH301 Biology Q Science > QA Mathematics |
| Divisions: | Faculty of Medicine > Warwick Medical School |
| Journal or Publication Title: | Biometrical Journal |
| Publisher: | Wiley - V C H Verlag GmbH & Co. KGaA |
| ISSN: | 0323-3847 |
| Date: | December 2007 |
| Volume: | Vol.49 |
| Number: | No.6 |
| Number of Pages: | 14 |
| Page Range: | pp. 903-916 |
| Identification Number: | 10.1002/bimj.200610373 |
| Status: | Peer Reviewed |
| Publication Status: | Published |
| Access rights to Published version: | Restricted or Subscription Access |
| URI: | http://wrap.warwick.ac.uk/id/eprint/30770 |
Data sourced from Thomson Reuters' Web of Knowledge
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