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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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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.

Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls

Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.

Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records

Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.

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