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Real World Evidence Benefits, Limits Explored In US FDA Demonstrations

 
• By Cathy Kelly

FDA's Jacqueline Corrigan-Curay lists three demonstrations now underway that are aimed at looking at different aspects of generating real world evidence and may inform the agency's evaluation of the data and methods.

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The US FDA is sponsoring demonstration projects to explore different applications of real world evidence in the regulatory process and patient care, according to Center for Drug Evaluation and Research Office of Medical Policy Director Jacqueline Corrigan-Curay.

"We're funding some demonstration projects … around what do we know about how the data can be used," she told a meeting on real world evidence sponsored by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the

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