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

Lorenz, Denny

Omschrijving

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.
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Schrijver
Lorenz, Denny
Titel
Development of a Standard Report for Signal Verification on Public Adverse Event Databases
Uitgever
ibidem-Verlag, Jessica Haunschild u Christian Schon
Jaar
2012
Taal
Engels
Pagina's
144
Gewicht
198 gr
EAN
9783838204321
Afmetingen
212 x 150 x 10 mm
Bindwijze
Paperback / softback

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