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Activity Number: 511
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #306480
Title: Evaluation of the Sensitivity of the Adverse-Events Signal by Screening Test
Author(s): Qian Graves*+ and Peng T Liu and Stuart Chirtel
Companies: FDA and FDA and FDA
Address: 5100 Paint Branch Pkwy, College Park, MD, 20740-3835, United States
Keywords: Screening Test ; Sensitivity and Specificity ; Predictive Power ; Adverse Events ; Signal Analysis

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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