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Real-World Data Could Get Boost From Trial Replication Project

Executive Summary

Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.

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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.

Tocilizumab COVID-19 Study Shows Bias Against Observational Studies, Harvard Prof Says

Study showing Roche’s Actemra decreased mortality in COVID-19 patients in ICUs by almost 10% was initially rejected by journal editors and then ignored by guideline writers and regulators. FDA officials and industry reps discuss what needs to be done to advance use of real-world evidence from observational studies.

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

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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