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Abstract Details
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Activity Number:
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319
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304095 |
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Title:
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A Case Study of Under-Running
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Author(s):
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Hua Liu*+ and Hongliang Shi and Jing Xu
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Companies:
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Millennium Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc.
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Address:
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35 Landsdowne Street, Cambridge, MA, 02139, United States
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Keywords:
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under-running ;
type I error control ;
survival endpoint
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Abstract:
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For phase III oncology clinical trials with time to event primary endpoint, some studies run into the situation of terminating prior to the design pre-specified number of events. In this case study, we present a real life example of such case. We will show the sponsor's approach on type I error control and sponsor's perspective on interpreting the observed results. We also discuss alternative view on interpreting the results. Results from simulations on different scenarios will be presented to illustrate the situation.
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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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