This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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330
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306671 |
Title:
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Meta-Analysis for Rare Adverse Event Data from Clinical Trials
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Author(s):
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Brenda Crowe*+
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Companies:
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Eli Lilly and Company
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Address:
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Lilly Corporate Center, Indianapolis, IN, 46285,
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Keywords:
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meta-analysis ;
safety ;
harms ;
rare adverse events
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Abstract:
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An integral part of the development of a drug is the assessment of adverse events through the evaluation of multiple clinical trials via meta-analysis. There are a variety of effect measures that can be used in the analysis, for example, risk difference, risk ratio and odds ratio. Rare adverse events are particularly problematic as there is a high chance of zero events in some treatment groups or entire studies. For trials with no events, neither the risk ratio nor the odds ratio is defined. In this presentation I will discuss various statistical aspects of meta-analysis for rare adverse events. These include choice of effect measure, continuity correction and analytical method, including a discussion of fixed vs. random effects, existing methods and new advances. A direct application is the assessment of cardiovascular risk in antidiabetic medications.
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Authors who are presenting talks have a * after their name.
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