FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE
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.
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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.
Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.
Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.