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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303404 |
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Title:
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Post-Randomization Subgroup: A Tale of Analysis in Early Responders
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Author(s):
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Yue Shentu*+
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Companies:
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Merck & Co., Inc.
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Address:
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126 E. Lincoln Ave, Rahway, NJ, 07065-0900,
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Keywords:
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subgroup analysis ; post-randomization ; early responders
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Abstract:
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In clinical trials, measurements of an endpoint at the primary timepoint are sometimes highly correlated with measurements at an earlier endpoint. This phenomenon prompts interest in the efficacy profile of "early responders" (i.e., those who responded to treatments according to certain efficacy criteria early on in the study). Direct comparisons in early responders between treatments are usually invalid due to the post-randomization nature of this subpopulation. Several analysis strategies are investigated to address three aspects of this problem: 1. imbalance of patient characteristics between treatments; 2. sensitivity of treatment comparison based on a post-randomization subgroup; 3. differential compositions of early responders in treatment and control due to heterogeneous distributions of early responses.
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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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