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Pre‐approval and post‐approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs

AIMS: Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorization (CMA). Whether, when taking CMA post‐approval confirmatory trials into account, the level of evidence and clinical benefit between CMA and standard approved (...

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Detalles Bibliográficos
Autores principales: Bloem, Lourens T., Bot, Rosa E., Mantel‐Teeuwisse, Aukje K., van der Elst, Menno E., Sonke, Gabe S., Klungel, Olaf H., Leufkens, Hubert G. M., Hoekman, Jarno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9303888/
https://www.ncbi.nlm.nih.gov/pubmed/34779004
http://dx.doi.org/10.1111/bcp.15141