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Activity Number:
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240
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Type:
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Contributed
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Date/Time:
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Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302398 |
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Title:
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Sensitivity Analysis for Treatment Drop-In in Oncology Clinical Trials
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Author(s):
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Cheng A. Rong*+ and Michael Wolf and Zhiying J. Pan and Xiang C. Zhang
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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 Drive, Thousand Oaks, CA, 91320,
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Keywords:
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Treatment Drop-in ; Treatment Crossover ; Overall Survival ; Oncology Clinical Trials
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Abstract:
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In early-line oncology clinical trials, evaluation of treatment effect of current line therapy on overall survival (OS) is often confounded by the issue of treatment drop-in, where patient enter into next line of treatment after they fail the current treatment due to disease progression. In this presentation, we will discuss several statistical methods on how to assess current line treatment effect on OS adjust for treatment drop-in as well as on how to address the potential impact of treatment drop-in to the comparison of OS. The sensitivity analysis will focus on several issues: first, how to set up reasonable assumptions for treatment drop-in; Secondly, how to assess whether the current treatment is truly effective; Thirdly, if it does, what are the potential ranges of treatment effect for the current therapy after adjusting for the treatment drop-in. Examples will be provided.
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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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