Early Detection of Pharmacovigilance Signals with Automated Methods Based on False Discovery Rates
Drug Safety(2012)
CESP Centre for Research in Epidemiology and Population Health
Abstract
Background: Improving the detection of drug safety signals has led several pharmacovigilance regulatory agencies to incorporate automated quantitative methods into their spontaneous reporting management systems. The three largest worldwide pharmacovigilance databases are routinely screened by the lower bound of the 95% confidence interval of proportional reporting ratio (PRR02.5), the 2.5% quantile of the Information Component (IC02.5) or the 5% quantile of the Gamma Poisson Shrinker (GPS05). More recently, Bayesian and non-Bayesian False Discovery Rate (FDR)-based methods were proposed that address the arbitrariness of thresholds and allow for a built-in estimate of the FDR. These methods were also shown through simulation studies to be interesting alternatives to the currently used methods.
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Key words
Proportional Reporting Ratio,Pharmacovigilance Database,False Discovery Rate Threshold,Traditional Detection,Spontaneous Reporting Database
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