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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A newly-translated guidance document from Japan’s drug and device regulator outlines the points that clinical trial sponsors should consider when using electronic methods to collect informed consent from participants.
Dozens of stakeholders weigh in on FDA’s draft guidance for decentralized clinical trials. They question having a higher bar for DCTs, the new requirement for a task log, and the presumption data collected in these trials may be more variable than that from traditional trials.
This second segment of a two-part article on a regional comparison of EU and US approaches to decentralized clinical trials highlights the differences between the two regions relating to the more practical aspects of setting up and running such studies.