Demonstration projects and clarity around FDA expectations are needed before "real-world evidence" on drug effectiveness can be reliably and routinely used for regulatory decision-making, industry, government, academic and other stakeholders said at a March 3-4 meeting convened by the Duke-Margolis Center for Health Policy.
Real-world evidence, such a pragmatic clinical trials and observational studies, could offer biopharma sponsors a quicker, less expensive means for obtaining new
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