This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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569
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306380 |
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Title:
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Adding a Prediction Interval Futility Analysis to a Group Sequential Trial
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Author(s):
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John Loewy* and David Dorer+
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Companies:
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ARIAD Pharmaceuticals and ARIAD Pharmaceuticals
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Address:
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, , ,
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Keywords:
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prediction interval ;
simulation ;
group sequential ;
power ;
futility ;
clinical trial
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Abstract:
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A Prediction interval (PI) simulation approach was introduced in a group sequential setting where the primary endpoint was analyzed using a cox proportional hazards model in order to assess conditional power under a variety of assumptions for time to event endpoints. PI methods have been advocated as a flexible and practical tool for quantitative monitoring of randomized controlled clinical trials. (Evans SR, Li L, Wei LJ, DIJ, 41:733-742, 2007). In our example the PI approach was very informative as an illustrative tool to demonstrate predictions of clinical trial outcomes under differing assumptions. Specifically, the PI approach was able to demonstrate that conducting a futility analysis too early in the evolution of a clinical trial is for all practical purposes uninformative.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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