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Modernizing Clinical Trials Leaves FDA ‘a Large Load of Work’

June 26, 2019, 5:36 PM

Innovative, targeted treatments will reach patients more quickly with the FDA’s overhaul of the costly, lengthy clinical trials system—but it’s going to take a while, the agency’s No. 2 said.

The Food and Drug Administration has been setting up a number of frameworks mandated through the 21st Century Cures Act, the sweeping biomedical law from 2016 (Pub. L. 114-255). One that came out last year, for instance, discusses how to harness patient-generated data such as electronic health records. But those frameworks are short-term goals that ultimately aim to modernize the infrastructure for conducting clinical trials, Amy P. ...