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Activity Number:
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256
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304247 |
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Title:
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Reporting the Proportion of Subjects with an Adverse Event from Multiple Studies
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Author(s):
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Christy Chuang-Stein*+ and Mohan Beltangady
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Companies:
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Pfizer Inc. and Pfizer Inc.
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Address:
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5857 Stoney Brook Road, Kalamazoo, MI, 49009,
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Keywords:
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CMH weighting ; Meta analysis ; Simpson's Paradox ; Study-size adjustment method
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Abstract:
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Experience has shown us that when data are pooled from multiple studies to create an integrated summary, the naïve analysis is vulnerable to the mischief of the Simpson's Paradox. Using the proportions of patients with adverse events as an example, we demonstrate this effect on both the comparison and the estimation of the proportions. In this paper, we emphasize the need for a meta analytic approach when comparing safety data between treatments based on data from multiple studies. We recommend reporting adjusted proportions when reporting proportions is necessary. In addition, we urge that guidelines on methods to quantify product risks be established so that risks can be communicated in a transparent, scientifically defensible and balanced manner.
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