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