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Activity Number:
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291
- SPEED: Biopharmaceutical Statistics
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Type:
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Contributed
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Date/Time:
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Tuesday, August 1, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323417
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Title:
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Sample Size Calculation to Support Local Submission
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Author(s):
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Zhuqing Yu* and Bidan Huang and Jun Zhao and lu cui
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Companies:
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AbbVie and AbbVie and AbbVie Inc. and Abbvie
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Keywords:
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Multi-regional Clinical Trial ;
Sample size calculation ;
Local submission
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Abstract:
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In multi-regional global clinical trials, it is often unrealistic to recruit the minimum number of subjects to satisfy the local submission requirement from each region. It is also likely that only part of the planned sample size in a region will have been fulfilled when the total number of subjects in the global trial has been reached. In order to support local filling, additional local trials may be required. We derive formulas for calculating sample sizes for the additional local trials assuming that the total sample size of the global trial has been determined. The calculations are based on three different criteria when combining the treatment effects from the global and local trial. The first criterion targets at least 80% probability that the effect in a particular region is at least half of that observed in the combined trial. The second criterion aims to have consistent effects across the pre-defined regions. And the third criterion requires a weighted average of the treatment effects from the particular region and the others, such that there is a desired proportion of that region's participants reflected in the combined trial (which is measured by the weight parameter).
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Authors who are presenting talks have a * after their name.
