Abstract:
:Pharmacovigilance systems aim at early detection of adverse effects of marketed drugs. They maintain large spontaneous reporting databases for which several automatic signaling methods have been developed. One limit of those methods is that the decision rules for the signal generation are based on arbitrary thresholds. In this article, we propose a new signal-generation procedure. The decision criterion is formulated in terms of a critical region for the P-values resulting from the reporting odds ratio method as well as from the Fisher's exact test. For the latter, we also study the use of mid-P-values. The critical region is defined by the false discovery rate, which can be estimated by adapting the P-values mixture model based procedures to one-sided tests. The methodology is mainly illustrated with the location-based estimator procedure. It is studied through a large simulation study and applied to the French pharmacovigilance database.
journal_name
Biometricsjournal_title
Biometricsauthors
Ahmed I,Dalmasso C,Haramburu F,Thiessard F,Broët P,Tubert-Bitter Pdoi
10.1111/j.1541-0420.2009.01262.xsubject
Has Abstractpub_date
2010-03-01 00:00:00pages
301-9issue
1eissn
0006-341Xissn
1541-0420pii
BIOM1262journal_volume
66pub_type
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