Pragmatic clinical trials in the context of regulation of medicines

The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authorization, there will never be enough patients studie...

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Bibliographic Details
Main Authors: Rolf Gedeborg, Charles Cline, Björn Zethelius, Tomas Salmonson
Format: Article
Language:English
Published: Upsala Medical Society 2019-01-01
Series:Upsala Journal of Medical Sciences
Subjects:
Online Access:http://dx.doi.org/10.1080/03009734.2018.1515280