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Activity Number: 592
Type: Topic Contributed
Date/Time: Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #311454 View Presentation
Title: Predicting the Probability of Success in a Cardiovascular Outcome Study
Author(s): Cong Han*+
Companies: Takeda
Keywords: CV outcome study ; prediction
Abstract:

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.


Authors who are presenting talks have a * after their name.

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