‘Clinical Trials System Is Broken,’ FDA Drug Chief Says

The nation’s clinical trial system is “broken” and needs to be changed to generate better evidence that leads to better patient outcomes, the head of the FDA’s drug center said.

“I personally believe, like many other people, that the clinical trial system we have right now is broken. It isn’t working to meet the objectives that we need it for,” Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, said Sept. 20. “Our inability to generate the needed evidence efficiently and in a cost-effective manner will continue to be a barrier to ...