Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says
Agency study deliberately not weighting RWE populations the same as RCTs it aims to duplicate. "We learn the most when we don't replicate," Harvard Medical School's Jessica Franklin tells the DIA annual meeting.
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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.
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.