Plans Press On To Harmonize Decentralized Clinical Trial Requirements In EU
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.
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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.
The new workplan for the EU's initiative on accelerating clinical trials lays out the timelines for a set of “priority actions,” such as mapping the European clinical trial environment and establishing a consolidated process for more efficiently managing scientific advice on trials.
The Danish regulator’s experience with reviewing and inspecting decentralized elements in clinical trials highlights concerns around the blurring of lines that divide the roles and responsibilities of sponsors and trial investigators.