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

 
• By Vibha Sharma

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. 

USA EU flag cracked wall background
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 August. EU regulators offered their harmonized perspective on the use...

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