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How to use FDA drug approval documents for evidence syntheses

Ladanie, Aviv and Ewald, Hannah and Kasenda, Benjamin and Hemkens, Lars G.. (2018) How to use FDA drug approval documents for evidence syntheses. BMJ, 362. k2815.

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Official URL: https://edoc.unibas.ch/69238/

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Abstract

There is compelling evidence that published trial information is selectively reported and that results not showing favourable effects of the tested treatments often remain unpublished.
Clinical trial information published by regulatory authorities such as the US Food and Drug Administration (FDA) may help to reduce such reporting biases.
FDA approval documents are long and do not follow the typical structure of medical journal articles, which may discourage reviewers from using them for evidence syntheses.
Our practical guidance on how to efficiently identify and use approval documents to find the relevant information may help promoting the use of this valuable data source for evidence syntheses.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
UniBasel Contributors:Ladanie, Aviv and Ewald, Hannah
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BMJ Publishing Group
ISSN:0959-8138
e-ISSN:1756-1833
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:26 Jul 2019 11:41
Deposited On:01 Mar 2019 13:48

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