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RWE: Comparators, Therapeutic Area May Be Key For Trial Replication

 
• By Sue Sutter

It may be easier to use observational study data to replicate randomized controlled trial results in certain therapeutic areas or where drugs were studied against each other instead of placebo, the US FDA’s David Martin says; the agency-funded DUPLICATE real-world evidence demonstration project has completed replication work on the first five trials, all of which are diabetes drug cardiovascular outcomes studies.

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Type of comparator and therapeutic area may be keys to success in replicating clinical trial results with real-world evidence. • Source: Shutterstock

The ability to use observational study data to replicate randomized controlled trial results may depend upon the comparators studied in the underlying trials as well as the therapeutic area, according to the head of the US Food and Drug Administration’s real-world evidence demonstration project program.

“Comparators matter,” David Martin, associate director for RWE analytics in the Office of Medical Policy, said in describing early learnings from trial replication projects. “It may be easier to replicate...

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