Shaking up clinical trials, one EHR at a time

Flatiron Health, once a wee tech startup that collated electronic health record data, is now attempting to help the FDA transform the way clinical trials are conducted. Now a unit of Roche, Flatiron plans to announce today that it is launching a major expansion of its research collaboration with the FDA — seeing how it can help the agency use real-world patient data in lieu of the information generated in traditional clinical trials.

The idea of supplanting clinical trial data is anathema to most scientists; efforts to replicate clinical trials with statistics have repeatedly failed. But Flatiron cofounder Zach Weinberg is a believer in the approach.

“You’ll see sometime this year the early replication work that we’ve done,” he told STAT’s Matt Herper. “We’re going to continue doing it with FDA to show it’s possible — when appropriate.”