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