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EU Decentralized Trials Guide Due Early In 2022

Long-Awaited Guidance Will Offer Feasibility Check

 
• By Vibha Sharma

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.

Doctor In Video Conference Call With Sick Patient
Real-time monitoring of patients in decentralized trials offers the possibility of improved protocol compliance • Source: Alamy

A long-awaited EU guideline explaining how sponsors can undertake decentralized clinical trials (DCTs) within the current legislative framework is expected to be issued early next year.

The guideline is being issued in response to increasing calls from industry on the need for harmonized EU guidance on...

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