Real-World Evidence Requires 'Leap Of Faith' For Industry, FDA – Gottlieb
US FDA Commissioner says agency will soon offer more clarity on using real-world evidence in drug development, but notes industry needs to take risks of its own.
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Agency is eager to engage with sponsors on ‘well thought-out proposals' to include real-world data sources in randomized studies, Office of New Drugs director Peter Stein says but adds that believability and robustness of the data are the agency’s primary concern.
CDER Director says current system is stifles innovation, calls for integration of health care and trial process.
The agency issued a final guidance spelling out reasonable applications of real-world device evidence and what factors must be considered when weighing whether data collected from routine care via means – such as electronic patient records or insurance claims – can help support a product approval or other regulatory decision.