Real-World Data Could Get Boost From Trial Replication Project
Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.
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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.
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.
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.