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Publicly available external pharmacovigilance databases, such as the FDA’s Adverse Event Reporting System (AERS) and the VigiBase database from the Uppsala Monitoring Centre (UMC), are not currently mandatory for pharmaceutical manufacturers when assessing potential drug safety signals. Experts recognize the importance of the adverse event information in these databases, and efforts are underway to evaluate their usefulness in supporting signal verification for internally detected signals. Software tools have been developed to integrate this external data into standard statistical methods for signal detection. Denny Lorenz's study examines the benefits of reports generated by the leading software ‘Empirica Signal’ in addressing common questions during the signal verification process. It provides a structural assessment of major external databases and statistical methods, discussing the selection of reports and differing opinions on the hierarchy of drug and event levels used for calculating statistical scores. The findings highlight that decisions regarding these levels and the depth of external analyses represent a trade-off between scientific goals and the financial and temporal constraints that companies face in this area.
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Development of a standard report for signal verification on public adverse event databases, Denny Lorenz
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- 2012
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