Activity Number:
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254
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2016 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #320898
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Title:
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Optimal Borrowing of Historical Control Data in Clinical Trials
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Author(s):
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Saurabh Mukhopadhyay* and Qi Tang and Alan Hartford
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Companies:
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AbbVie and AbbVie and AbbVie
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Keywords:
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historical data ;
clinical trials
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Abstract:
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Many clinical trials involve placebo or active control arm for which similar clinical data already exists from historical studies. Due to various considerations it is often very appealing to leverage such historical data in the control arm. We plan to present a novel way of borrowing the information while attaining a desired power level and maintaining the stipulated type I error rate. A few variations of models and decision rules are considered to study their relative merits in a specific application.
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Authors who are presenting talks have a * after their name.