Brigid Bondoc spoke to Pink Sheet about the U.S. Food and Drug Administration's draft guidance on decentralized clinical trials, which describes when investigators can delegate trial-related activities to local health care providers.
The guidance specifies that when permitted by the trial protocol, investigators may allow local health care providers (HCPs) to complete trial-related procedures that require in-person interactions with trial participants, such as physical examinations and other medical procedures. According to Brigid, this may require sponsors to think more about the line between investigators who may never be physically present with the patient and local health care providers.
"Is this a situation where the local HCP is going to have to have training?" Brigid said. "Will they become a sub-investigator? How do you get information from health care encounters that aren't planned? And if a subject is interacting with the health care system outside of the trials, what is the best way of capturing that data?"
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