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

Executive Summary

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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