The Food and Drug Administration is launching a new initiative aimed at further testing use cases for real-world evidence by predicting the outcomes of randomized controlled trials, FierceBiotech reports.
“This project will play a major role in determining the future of how drugs are developed and approved,” Carolyn Magill, Aetion CEO, said in a statement. “Data collected from the front lines of clinical care can often provide a more complete picture on how treatments affect patients not represented in clinical trials, but the regulatory process must ensure transparency.”
Brigham and Women’s Hospital’s Jessica Franklin, the project’s lead, says being able to predict the outcomes of clinical trials could suggest “in certain circumstances real-world evidence could potentially substitute for a trial.”
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