EU Countries Focus On National Best Practices For Decentralized Trial Approvals & Inspections

 
• By Vibha Sharma

The EU recommendation paper on decentralized clinical trials (DCTs) marked an important “first step” on the direction the European regulatory network wants to take with DCTs. Member states are now focused on reviewing and tracking DCTs to gain experience before considering the need for any updates to the recommendation paper. 

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EU Regulators Are Keen To Facilitate Decentralized Clinical Trials • Source: Shutterstock/Alfa Photo

Six months after the European medicines regulatory network issued harmonized recommendations on conducting decentralized clinical trials (DCTs), EU member states are focused on implementing these perspectives in their national environments.

The pan-EU DCT recommendation paper will form the basis for “best practices” for authorizing and inspecting clinical trials in Europe, said Ditte Zerlang Andersen, EU project manager and special advisor at the Danish Medicines Agency

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