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Activity Number:
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60
- Adaptive Design and Statistical Consideration in Clinical Trials
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 30, 2017 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324275
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Title:
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Adaptive Design and Statistical Consideration in Clinical Trials
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Author(s):
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Steven Sun* and Grace Liu and Tianmeng Lyu
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Companies:
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and Johnson & Johnson and Univ. Minnesota Biostatistics Dept.
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Keywords:
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Adaptive design ;
Clinical trial ;
surrogate endpoint
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Abstract:
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Adaptive seamless phase II/III design is appealing since it can save time in drug development by combining traditional phase II design and phase III design together. Adaption is often based on the result of the primary endpoint at the planned interim analysis. However, one big challenge is that the primary endpoint may take too long to mature for adaption such as treatment selection. In this talk, we will focus on the seamless design which allows treatment selection based on surrogate endpoint at the interim analysis. A simulation study will be used to illustrate how we can enrich our knowledge about the seamless design and guide us for optimal sample size determination and clinical cutoff selection.
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Authors who are presenting talks have a * after their name.
