Sponsors interested in building real-world elements into randomized studies should begin by focusing on the main objectives underlying the trial and then figure out the real-world data sources needed to get there, experts said at a recent Duke-Margolis Center for Health Policy meeting on real-world evidence.
“No matter what type of study we’re designing, we need to start with a clear understanding of which outcomes matter most,” said Sean Tunis, founder and senior strategic advisor with...
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