Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis

Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis

Objective To compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition.Design Cross sectional analysis.Setting US and Europe.Pop...

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Bibliographic Details
Main Authors: Jamie J Kirkham, Sarah L Gorst, Paula R Williamson, Susanna Dodd, Ian J Saldanha, Rebecca Fish, Deborah A Hall, Dominic Trépel, Pamela Jacobsen
Format: Article
Language:English
Published: BMJ Publishing Group 2022-12-01
Series:BMJ Medicine
Online Access:https://bmjmedicine.bmj.com/content/1/1/e000233.full
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