Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference.
“[R]eal world evidence is just clinical evidence. There aren’t two things that we should be thinking about differently,” Felipe Aguel, deputy director in the Office of Clinical Evidence and Analysis at the Center for Devices and Radiological Health (CDRH), told attendees at the meeting.
Aguel said FDA has encountered misconceptions around RWE both internally and externally over the last few years. One of the most common misconceptions is that published literature is considered RWE. While Aguel acknowledged some published literature can be RWE, like when literature reports on RWE studies, it is not true of all published literature. For example, if published literature is a report of one or more clinical trials, that is not considered RWE, he explained…
