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Companies Urged Not To View EU Privacy Law As A Barrier To Conducting Decentralized Trials

 
• By Vibha Sharma

A senior regulator from the European Medicines Agency says that while the EU General Data Protection Regulation can be intellectually challenging, the law is needed, and it should not deter companies from conducting decentralized clinical trials because of concerns they might have over the use of digital tools to capture and process patient and trial data.

Digital Clinical Trial
Decentralized Clinical Trials Commonly Rely On Digital Tools To Capture Patient Data • Source: Shutterstock/Alfa Photo

Companies that are considering conducting decentralized clinical trials (DCTs) should not be put off from doing so because they might be worried that the EU General Data Protection Regulation (GDPR) could make it difficult for them, according to Fergus Sweeney of the European Medicines Agency.

They should instead view the data protection legislation “as an enabler of research,” said Sweeney, who heads the EMA’s clinical studies and manufacturing task force and was speaking

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