Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets' Utility And Limitations
A European pharmacoepidemiology study helped reassure advisory committee members about the constipation drug’s cardiovascular safety, but confounding factors limited interpretability of the results and information about the study population’s racial makeup was lacking; nevertheless, panelists urged a similar study be conducted to assess potential carcinogenic and psychiatric risks.
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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.
US FDA may have set record for new drug approvals during 2018, but agency actually issued press releases highlighting approvals less often than it has in the past.
Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.