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EU Regulators Told To ‘Normalize’ Decentralized Clinical Trials

 
• By Vibha Sharma

EU drug regulators have received some candid responses from trial sponsors and other stakeholders on the aspects that should be urgently addressed in the next iteration of their guidance on decentralized clinical trials.

Digital Clinical Trial
EU DCT Recommendation Paper Places Additional Obligations On Study Sponsors • Source: Shutterstock/Alfa Photo

EU regulators looking for feedback on what stakeholders made of their recommendation paper on decentralized clinical trials, which was issued nearly a year ago, have been flooded with suggestions for improvement, starting with keeping an open mind and not holding DCTs to a higher degree of scrutiny than conventional site-based trials.

Regulators were told to refrain from “making assumptions” on what patients or principal investigators might prefer in a trial, and to provide guidance on how to involve local health care...

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