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EMA Undertook 14 RWE Studies In 2018 To Complement Company Data

 
• By Vibha Sharma

Pharmacoepidemiologists and statisticians at the European Medicines Agency used databases of electronic healthcare records to support decision-making by its scientific committees using real-world evidence.

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The EMA Has Been Performing Database Studies Since 2013 • Source: Shutterstock

Real-world evidence (RWE) studies are increasingly being undertaken, not just by drug companies but also regulatory authorities, to better understand the benefit-risk profile of medicines. In 2018, the European Medicines Agency used two in-house databases of electronic healthcare records to perform 14 studies to provide RWE to its scientific committees.

These studies were performed by EMA staff – pharmacoepidemiologists and statisticians – to generate evidence in order to complement the data submitted by marketing authorization holders or information retrieved from...

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