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Activity Number:
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65
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Type:
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Contributed
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Date/Time:
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Sunday, July 29, 2007 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309178 |
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Title:
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Sample Size Estimation for the Phase III Confirmatory Clinical Trials Considering the Uncertainty of the Effect Size
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Author(s):
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Zhe Shang*+ and Yawei Zhang
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Companies:
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Novartis Pharmaceuticals and University of Pennsylvania
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Address:
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One Health Plaza, East Hanover, 07936,
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Keywords:
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confirmatory clinical trials ; sample size ; effect size
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Abstract:
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Sample size estimation is a crucial component during the designing stage of phase III confirmatory clinical trials. Wang, Hung, and O'Neill (2004) pointed out that the estimates of effect sizes obtained from previous clinical trials and past literatures are often too optimistic for the planning of the phase III confirmatory trials. Sample size estimation considering the uncertainty of the variance was studied by Julious and Owen (2006). In the presentation, we developed three sample size estimation formulas which take the uncertainty of effect size into consideration. We discussed the properties of our sample size estimation formulas and compared them with the traditional sample size calculation formula. We also pointed out how our sample size formulas can be applied to the binary response data. Finally we applied our sample size estimation formulas to a real phase III clinical trial.
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