Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit

BACKGROUND: Single-arm trials (SATs) can sometimes be used to support marketing authorization of anticancer medicinal products in the European Union. The level and durability of antitumor activity of the product as well as context are important aspects to determine the relevance of trial results. Th...

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Detalles Bibliográficos
Autores principales: Mulder, J., Teerenstra, S., van Hennik, P.B., Pasmooij, A.M.G., Stoyanova-Beninska, V., Voest, E.E., de Boer, A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10163162/
https://www.ncbi.nlm.nih.gov/pubmed/37054504
http://dx.doi.org/10.1016/j.esmoop.2023.101209

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10163162/
https://www.ncbi.nlm.nih.gov/pubmed/37054504
http://dx.doi.org/10.1016/j.esmoop.2023.101209

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