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UK, US & Canada Regulators Explain Why Decentralized Trials May Get A Closer Look

 
• By Vibha Sharma

Decentralized clinical trials are subject to the same regulatory requirements as traditional site-based trials, but are of special interest to regulators because they represent a new way of working.

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Decentralized Trials Can Be More Complex Than Conventional Site-Based Trials • Source: Shutterstock

While the use of decentralized elements in clinical trials is gaining momentum, a common refrain by sponsors wanting to experiment with new approaches on this front is that regulators tend to review such studies more aggressively than traditional trials conducted at investigative sites.

Decentralized clinical trials (DCTs) include elements that allow some or all trial-related tasks to be conducted in or a near...

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