Abstract Details
Activity Number:
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592
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311454
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View Presentation
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Title:
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Predicting the Probability of Success in a Cardiovascular Outcome Study
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Author(s):
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Cong Han*+
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Companies:
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Takeda
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Keywords:
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CV outcome study ;
prediction
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Abstract:
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In some cardiovascular outcome studies, a pre-marketing analysis is performed to rule out a certain amount of excess risk and gain marketing approval; afterwards a post-marketing analysis is performed to rule out a smaller amount of excess risk. In practice, each of these two analyses may be a series of group-sequential analyses. In this talk, the issue of using pre-marketing analysis results to predict the probability of success in the post-marketing analysis will be examined; such prediction may be based on unblinded results or partially unblinded results (only with the knowledge of whether the pre-marketing margin has been ruled out). Both non-Bayesian and Bayesian views will be presented.
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Authors who are presenting talks have a * after their name.
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