MedPage Today October 11, 2019
WASHINGTON — Changes in the way data are being collected are on track to revolutionize the use of real-world data in drug approvals, Janet Woodcock MD, the longtime director of the FDA’s Center for Drug Evaluation and Research, said here.
“Traditional drug development programs … don’t usually get much insight into who to use a drug in and who not to use a drug in,” Woodcock said Thursday at an event on the future of health data sponsored by Datavant, a company that helps healthcare systems with patient identification. “Are there ways we can capture and utilize the data collected … to make the clinical trial enterprise more effective and efficient?”
The widespread use of electronic health records has drastically...