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FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE

 
• By Cathy Kelly

Results from the US Food and Drug Administration’s RCT DUPLICATE demonstration are in. The findings both legitimize certain real-world evidence studies and also highlight the challenges involved in using RWE to replicate randomized clinical trials.

RWE Studies Replicated Results From About 50% of RCTs In Demo • Source: Shutterstock

The FDA-funded RCT DUPLICATE demonstration has found that real world studies based on observational claims data “can come to similar conclusions as trials when we’re able to emulate them well,” Brigham and Women’s Hospital associate professor Shirley Wang reported during a meeting on project results hosted by the Duke Margolis Center for Health Policy on 10 May.

However, “it’s more challenging to emulate trials that are designed with many constraints to show effects under ideal conditions,” Wang continued. “Unsurprisingly, we had greater success replicating results in trials...

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