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.

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.

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US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 

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German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 

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