Principles-Based vs Prescriptive: How US & EU Compare In Their Approach To Decentralized Trials

In this regional comparison, regulatory experts at a US-based decentralized clinical trials (DCT) firm discuss their views on how the FDA’s draft DCT guideline compares with the pan-EU recommendation paper on this topic. This first segment of a two-part article dwells on the thinking behind why US and EU regulators tend to go down different paths. 

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US And EU Recommendations On Decentralized Trials Reflect The Philosophical Differences Between Regulators In The Two Regions • Source: Shutterstock

Both US and EU regulators recognize the important potential benefits and value of decentralized clinical trials (DCTs) and are keen to support such studies. Their respective guidelines on DCTs - issued just five months apart - are largely similar but have some notable differences.

The US Food and Drug Administration published its draft DCT guideline in May, with stakeholder comments being accepted until 1...

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