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Randomized controlled trials and real-world evidence for market access and surveillance of high-risk products: the example of paclitaxel

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In 2018 and 2020, two meta-analyses using summary-level data from randomized controlled trials reported worse mortality following the application of paclitaxel-coated stents and balloons in femoropopliteal and crural arteries. These results initiated a heated global discussion concerning the validit...

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Main Authors: Behrendt, Christian-Alexander (Author) , Rother, Ulrich (Author) , Rümenapf, Gerhard (Author) , Uhl, Christian (Author) , Görtz, Hartmut (Author) , Böckler, Dittmar (Author)
Format: Article (Journal)
Language:English
Published: December 2020
In: Gefässchirurgie
Year: 2020, Volume: 25, Pages: 29-36
ISSN:1434-3932
DOI:10.1007/s00772-020-00726-0
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1007/s00772-020-00726-0
Verlag, lizenzpflichtig, Volltext: https://link.springer.com/article/10.1007/s00772-020-00726-0
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Author Notes:C.‑A. Behrendt, U. Rother, G. Rümenapf, C. Uhl, H. Görtz, D. Böckler ; Kommission PAVK und Diabetischer Fuß der DGG e.V.
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Randomisierte kontrollierte Studien und Real-World-Evidence in der Marktzulassung und Überwachung von Hochrisikoprodukten: das Beispiel Paclitaxel by Behrendt, Christian-Alexander (Author) , Rother, Ulrich (Author) , Rümenapf, Gerhard (Author) , Uhl, Christian (Author) , Görtz, Hartmut (Author) , Böckler, Dittmar (Author) ,


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