1. Pink Sheet

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 the Center for Medical Technology Policy and former chief medical officer at the US Centers for Medicare

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