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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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.
The upcoming EU guideline on decentralized clinical trials is the result of a “learning by doing” exercise and builds on various pilots and initiatives launched by different member states.