Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless said during a recent conference that the agency was “open for business” for considering real-world evidence (RWE) for additional uses of new cancer drugs, BioPharma Dive reports.
Sharpless said that while randomized controlled trials remain key, he acknowledged “there is a need for flexibility.”
“The FDA is always going to want to see really well-designed beautiful trials with convincing endpoints,” he said during the BIO conference in Philadelphia. “If you can do a large [randomized controlled trial] with overall survival as your outcome, there is nothing better.”
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