Using real-world data could improve patient recruitment for studies and potentially bring down the costs of drug development, the FDA’s clinical science chief said.
“The cost of doing trials at present is staggering,” Robert Temple said during a March 7 meeting on real-world evidence. “If there were a way to more efficiently find patients, it would be an enormous gain.”
The push toward incorporating real-world evidence into the Food and Drug Administration’s regulatory decision of new drugs marks a shift away from relying solely on randomized controlled trials, which have traditionally served as the gold standard for evidence generation to...
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