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Master Protocols Offer Another Avenue To Advance Real-World Evidence

 
• By Brenda Sandburg

Experts discuss how master protocols can help produce more comparable real-world evidence and draw more investigators into studies. FDA CMO Hilary Marston says payers must be more involved in discussion of the value of real-world data.

Real world
Researchers discuss ways to advance use of real-world evidence in medical product development • Source: Shutterstock

In the ongoing quest to expand the use of real-world evidence in drug development, researchers are now focusing on the potential use of master protocols to support multiple RWE studies under a single research protocol.

Key Takeaways

  • Master protocols should allow for an expansive number of investigators in RWE studies.

  • AI has the potential to transform coding, reimbursement, and data generation for physicians

The Duke-Margolis Center for Health Policy at Duke University focused on these efforts at a meeting last month on

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