EMA-developed method helps detect adverse events

A statistical signal-detection method shows promising results for early detection of adverse drug events. The method, developed by the European Medicines Agency and used in conjunction with adverse event data from its EudraVigilance database, shows "significantly earlier" detection in more than half of the cases studied.

EudraVigilance is the EU database for adverse event reports.

The "significantly earlier" designation is in comparison with routine pharmacovigilance. The agency says in an announcement that it sees a "strong additive role" of the method. And it concludes that a combination of established pharmacovigilance systems--trials, active surveillance, safety update reporting--and statistical signal detection provides optimal safety monitoring.

The agency is now using the method in its drug authorization processes.

- here's the announcement

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