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Three design aspects for high quality post-marketing cohort studies

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Spelsberg and colleagues showed that ascertaining the results of post-marketing safety studies is challenging.1 In the US and Europe, brand name drug manufacturers are required to summarise data from post-marketing… Click to show full abstract

Spelsberg and colleagues showed that ascertaining the results of post-marketing safety studies is challenging.1 In the US and Europe, brand name drug manufacturers are required to summarise data from post-marketing studies and submit them to the regulatory authority.2 Aspects of these reports should be made publicly available to inform the medical community about important emerging data and allow the scientific community to evaluate …

Keywords: design aspects; aspects high; post marketing; three design; post

Journal Title: British Medical Journal
Year Published: 2017

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