EU Decentralized Trials Guide Due Early In 2022
Long-Awaited Guidance Will Offer Feasibility Check
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.
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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.
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.”
AI could help companies comply with regulations like GDPR and IDMP, apart from optimizing clinical trial processes, Accenture’s managing director leading R&D analytics in North America says, as he lists cases where the firm drove cost savings.