Is It Tougher To Conduct Decentralized Trials In The EU? ‘Don’t Fall Prey To Negative Narrative’
A senior EMA official says companies should use “a little imagination” when confronted with EU member state-specific barriers to decentralized trials and not “just freeze in front of the headlights.”
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Mira Zuidgeest is the principal investigator of a key EU study that proposes to compare fully remote, hybrid and conventional clinical trial approaches. She talks to the Pink Sheet about how the study might help understand “where we're heading with decentralized clinical trials.”
A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.
Participants from all areas of the research community will be able to share their perspectives on decentralized clinical trials with the EU regulators, who plan to publish recommendations on the topic later this year.