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Abstract Details
Activity Number:
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511
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Statistics in Epidemiology
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Abstract - #306480 |
Title:
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Evaluation of the Sensitivity of the Adverse-Events Signal by Screening Test
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Author(s):
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Qian Graves*+ and Peng T Liu and Stuart Chirtel
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Companies:
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FDA and FDA and FDA
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Address:
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5100 Paint Branch Pkwy, College Park, MD, 20740-3835, United States
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Keywords:
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Screening Test ;
Sensitivity and Specificity ;
Predictive Power ;
Adverse Events ;
Signal Analysis
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Abstract:
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The "sensitivity" and "specificity" of the adverse-events signal can be evaluated by the same procedures as a screening test, but they often encounter the following difficulties: 1) No clear-cut definition for positive or negative of "disease" (regulatory action) and "test" (signal), 2) Complementary relation between the sensitivity and specificity, 3) Bias in selecting pairwise (signal- event) samples which could yield any desire degree of signal sensitivity, and 4) Unequal impact of signal on regulatory action. This article discusses some statistical fallacies in signal sensitivity evaluation and provides remedies.
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Authors who are presenting talks have a * after their name.
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