This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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583
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Type:
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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 - #308135 |
Title:
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Sensitivity Analysis for PFS
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Author(s):
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Alicia Zhang*+ and Alan Rong and Ying Tian and Michael Wolf
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Companies:
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Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc.
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Address:
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One Amgen Center Dr., Thousand Oaks, CA, 91320, USA
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Keywords:
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sensitivity analysis ;
PFS ;
oncology therapeutic trials
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Abstract:
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Sensitivity analysis for PFS has become increasingly important in oncology therapeutic trials due to the fact that more trials use PFS (from central review) as the primary endpoint. Potential biases could mislead the primary analysis results and hence the impact should be assessed. Those biases come from many aspects including the tumor assessment frequency, tumor assessment interval, truncation of central review by local disease progression, open-label study and use of the subsequent anti-cancer therapies. In this presentation, we will present some key issues for PFS analyses raised from several P3 mCRC studies and propose some sensitivity analysis methods with different degrees of conservativeness to address these issues. Interpretation of those analyses including the impact to the estimation of treatment effect and the control of type 1 error rate will be discussed.
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Authors who are presenting talks have a * after their name.
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