Development of a Standard Report for Signal Verification on Public Adverse Event Databases.

Publically available external pharmacovigilance databases, such as the American FDA's Adverse Event Reporting System (AERS) and the VigiBase database of the Uppsala Monitoring Centre (UMC), are currently not obligatorily taken into account by the pharmaceutical product manufacturers regarding potential drug safety signals. The value of this information on adverse events that is revealed in these databases is well acknowledged by product experts. These external data sources are now being evaluated for their suitability to at least support signal verification for signals which have been detected within a pharmaceutical company. The appropriate software tools needed to support the integration of this information into the commonly used statistical methods of signal detection have been developed. In his study, Denny Lorenz evaluates the benefit of the reports that the market leading software 'Empirica Signal' generates for common questions during the signal verification process. The major external databases and statistical methods are described and structurally assessed. Besides the selection of reports, contrary opinions on the hierarchy levels of drug and event on which the statistical scores are calculated, are discussed. The study demonstrates that the decision on these levels and the depths of the external analyses itself is a trade-off between scientific ambitions and the limits of time and money that companies are willing to invest in this endeavor.

Autorentext

Denny Lorenz, born in 1982, studied business informatics at the Berlin School of Economics (University of Applied Science) from 2002 to 2005 and Consumer Health Care at the Charité Universitätsmedizin Berlin from 2009 to 2011. Currently the author is working for the pharmacovigilance department of one of the leading German research-based pharmaceutical companies.