Europe’s common data conundrum

What it would take for EMA to adopt a common data model

The benefits of deploying a common data model for pharmacovigilance surveillance and postmarket studies are clear, but an EMA workshop held in December to discuss different models highlighted challenges to implementation.

Topping the list are sources of sustainable funding and compliance with the EU’s strict privacy laws.

The agency is in the early stages of deciding whether to adopt a common data model, which would standardize safety and efficacy data from a variety of different sources, such as electronic health records, insurance claims or registries.

EMA’s current pharmacovigilance system, EudraVigilance, relies solely on spontaneous reporting of adverse drug reactions by companies, doctors and patients. In 2016, the EudraVigilance system received more than 1.2 million adverse drug reaction reports.

Yet the literature is full of studies demonstrating that adverse drug reactions are highly underreported. For instance, a 2006 review by researchers from independent academic research institute Drug Safety Research Unit published in Drug Safety found that as few as 5% of adverse drug reactions were reported to

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