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Trust and transparency in clinical trials of medical devices

Regulatory approval of high-risk cardiovascular devices is on the basis of clinical studies submitted with a premarket approval application. Failure to publish many of these studies in peer-reviewed literature, and major discrepancies between premarket approval submissions and those studies that are...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Veröffentlicht in:Nat Rev Cardiol
Hauptverfasser: Kramer, Daniel B., Cutlip, Donald E.
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2015
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4698975/
https://ncbi.nlm.nih.gov/pubmed/26194550
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/nrcardio.2015.112
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