4:00 PM
Feb 06, 2018
 |  BioCentury  |  Regulation

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 regulators.

“A common data model is a pragmatic approach to further developing the European safety surveillance system for drugs and vaccines.”

Andrew Bate, Pfizer

Establishing a common format that allowed integration of multiple sources of safety and efficacy data could capture a greater proportion of adverse events, and also would allow EMA and sponsors to make greater use of real-world data for postapproval studies, or to support label expansions in the context of EMA’s adaptive licensing pathway.

“A common data model is a pragmatic approach to further developing the European safety surveillance system for drugs and vaccines,” Pfizer Inc.’s Andrew Bate told BioCentury in an email. Bate is senior director analytics team lead at Pfizer and was a participant in the workshop.

Lincoln Tsang, a life sciences lawyer at Arnold & Porter Kaye Scholer, told BioCentury that a common data model could also help HTA bodies with decisions on access and reimbursement. Tsang was previously an adviser to EMA and head of biologicals at...

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