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Stat Methods Med Res. 2016 Apr;25(2):615-29. doi: 10.1177/0962280212462295. Epub 2012 Oct 14.

Comparison of two drug safety signals in a pharmacovigilance data mining framework.

Author information

1
Inserm, CESP Centre for Research in Epidemiology and Population Health, Biostatistics, Villejuif, France Univ Paris Sud, Villejuif, France pascale.tubert@inserm.fr.
2
Inserm U657, Univ. de Bordeaux, Bordeaux, France.
3
Inserm, CESP Centre for Research in Epidemiology and Population Health, Biostatistics, Villejuif, France Univ Paris Sud, Villejuif, France.

Abstract

Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database.

KEYWORDS:

Bayesian decision theory; Gamma Poisson Shrinker model; Pharmacovigilance; Proportional Reporting Ratio; adverse drug reactions; beta distribution; data mining; gamma mixture; ratio distribution; signal

PMID:
23070598
DOI:
10.1177/0962280212462295
[Indexed for MEDLINE]

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