Abstract Details
Activity Number:
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355
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Type:
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Contributed
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Date/Time:
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Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #308608 |
Title:
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A Comparison of Group Sequential Strategies for Three-Arm Noninferiority Trials
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Author(s):
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Toshimitsu Ochiai*+ and Toshifumi Sugitani and Yuko Ohno and Toshimitsu Hamasaki
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Companies:
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Shionogi & Co., Ltd. and Osaka University Graduate School of Medicine and Osaka University Graduate School of Medicine and Osaka University Graduate School of Medicine
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Keywords:
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Three-arm non-inferiority trial ;
Group sequential design ;
Power ;
Sample size estimation ;
Predicted intervals
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Abstract:
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When designing a clinical trial to show that an experimental intervention is effective, a three-arm non-inferiority design including both a placebo and active controls may be optimal because assay sensitivity (AS) can be assessed within the trial and the non-inferiority (NI) of experimental intervention to active control can be evaluated. In this presentation, we consider two scenarios for the assessment of NI and AS in three-arm non-inferiority trials within the framework of group sequential designs. The statistical significance for NI and AS is established jointly at the same interim point of the trial in one scenario, and is demonstrated at any interim point until the end of the trial in the other scenario. We define the power for each scenario and outline sample size calculation including the maximum and expected numbers. A simulation study is then performed to illustrate the aspects of each scenario, which are compared with a conventional fixed design. Furthermore, we discuss the use of predicted intervals as a flexible and practical tool for quantitative monitoring of the potential effect size estimates and associated precision for NI and AS.
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