"In a broad-ranging draft guidance published May 2, the FDA directs sponsors to communicate with agency staff early on to parse through the specifics of their trial design, and it lays out a roadmap for how to collect data and involve healthcare providers. The FDA received 85 comments on the guidance by the time the comment period closed on Tuesday."

Also of interest:
"stakeholders are largely welcoming the guidance, but are asking the agency to re-examine several aspects, including allowing more flexibility in clinical trial design and loosening the recommendation that participant information be stored at a physical location."

From an article about decentralizing clinical trials. Warning: if you click the link, you will use up one of your 4 free articles. This site is affiliated with Feuerstein so there is NO way I will pay for a subscription.

https://endpts.com/phrma-walgreens-mayo-clini...-guidance/