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Should regulatory data from the EMA and the FDA be included in systematic reviews?

An editorial in the Cochrane Library from the last week argues that clinical trial information from regulators should be included in systematic reviews of treatments. In 2014, the authors of the editorial showed that drug reports from the European Medicines Agency (EMA) and the US Food and Drug Agency (FDA) contained enough information to be used in a systematic review. In another study, they found that when that information is included in a systematic review of a treatment, it can change the results.

To encourage more researchers to use regulatory information in their systematic reviews, the authors of the editorial suggest that the Cochrane Handbook, which explains how to do a Cochrane systematic review, be updated to include tips on how to search the regulatory databases for otherwise unpublished data.


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Ryan co-runs Aspire Scientific, a dynamic, forward-thinking medical writing agency. Ryan has a passion for innovation, science and ethical communication.

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