Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

INTRODUCTION: The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. OBJECTIVE: To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency...

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Bibliografiska uppgifter
I publikationen:BMJ Open
Huvudupphovsmän: Hatswell, Anthony J, Baio, Gianluca, Berlin, Jesse A, Irs, Alar, Freemantle, Nick
Materialtyp: Artigo
Språk:Inglês
Publicerad: BMJ Publishing Group 2016
Ämnen:
Pharmacology and Therapeutics
Länkar:https://ncbi.nlm.nih.gov/pmc/articles/PMC4932294/
https://ncbi.nlm.nih.gov/pubmed/27363818
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2016-011666
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