Episodes
Friday Sep 06, 2019
Real World Data Expanding into Label Expansion
Friday Sep 06, 2019
Friday Sep 06, 2019
Where is real world data providing evidence that impacts therapeutic product development? “We're learning that, right now, the near-term uses are probably around label expansion and around providing information on new populations that's valuable but wasn't captured in randomized clinical trials or could not be captured in those trials,” explains Nicole Mahoney, Senior Director, Regulatory Policy, for Flatiron Health. “The real thing that you have to ask is: What decisions are you driving at? What is the regulatory question that you're trying to support with real world data?”
Version: 20240731
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