Signal detection pharmacovigilance

Meyboom RHB, Egberts ACG, Edwards IR, Hekster YA, de Koning FHP, Gribnau FWJ. Principles of signal detection in pharmacovigilance. Drug Saf 1997 16 355-65. 

The term "signal detection" has been used by some authors and pharmacovigilance professionals synonymously with statistical data mining or disproportionality analyses of large adverse event databases. This is a misnomer, however, as signal detection is not limited to a narrow range of data sources or analytical approaches. 

Source Adapted from the Report of CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance, Council for International Organizations of Medical Sciences (CIOMS), Geneva, Switzerland, 2010. With permission, CIOMS. 

Harpaz R, DuMouhcel W, LePendu P, Bauer-Mehren A, Ryan P, Shah NH. 2013. Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system. Clin. Pharmacol. Ther. 93 539-546. 

CIOMS VIII Application of signal detection in pharmacovigilance... 

Observational studies Analysis of postmarketing pharmacovigilance data with modified signal detection methods was performed to compare the adverse event... 

Patadia VK, Coloma P, Schuemie MJ, EU-ADR Consortium et al (2015) Using real-world healthcare data for pharmacovigilance signal detection the experience of the EU-ADR project Expert Rev CUn Pharmacol 8 95-102... 

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