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Feb 25

STAT Magazine: Can Roche’s little tech startup help the FDA change clinical trials? (FLATIRON)

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"Could a startup founded by two guys in their 20s change the way medical researchers study patients? The Food and Drug Administration is open to the possibility.

Flatiron Health began as a small New York tech company trying to use real-world data from patient electronic medical records to replace more traditional clinical trial data. Then it raised $328 million, launched a modest collaboration with the FDA to study the use of its so-called “real-world” data in 2016, and entered partnerships with just about every major drug firm. Last year, it was acquired for $1.9 billion by the Swiss drug giant Roche Holding."


"On Monday, Flatiron will announce that it is renewing and expanding its research relationship with the FDA, allowing the agency to further test the ways in which it can it can use Flatiron’s data in lieu of more traditional clinical trial data to make decisions. “The FDA recognizes the tremendous importance of analyzing treatment data from the real world,” Dr. Richard Pazdur, director of FDA’s Oncology Center of Excellence, said in a statement from Flatiron."


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