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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...

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Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
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Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

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Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.