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Randomized Study Objectives Should Drive Choice Of Real-World Data Sources, Experts Say

 
• By Sue Sutter

Start with the trial’s primary objective and then figure out which RWD sources could help inform that outcome, experts say at Duke-Margolis meeting; however, design and underlying objectives of Novo Nordisk’s real-world use of trial of Ozempic have the FDA’s Robert Temple suggesting success will be a ‘longshot.’

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Focus on a study's primary objective when deciding what type of real-world data sources to leverage. • Source: Shutterstock

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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