FDA’s Decentralized Trial Guidance: Investigator, Health Care Provider Demarcation Raises Questions
The investigator's ability to delegate trial-related activities to local HCPs could create operational and reimbursement challenges, as well as potentially boost patient recruitment, stakeholders said. The guidance does not address digital divide and how to deal with a massive influx of data.
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Dozens of stakeholders weigh in on FDA’s draft guidance for decentralized clinical trials.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.
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.