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Do single‐arm trials have a role in drug development plans incorporating randomised trials?

Often, single‐arm trials are used in phase II to gather the first evidence of an oncological drug's efficacy, with drug activity determined through tumour response using the RECIST criterion. Provided the null hypothesis of ‘insufficient drug activity’ is rejected, the next step could be a rand...

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Detalles Bibliográficos
Autores principales: Grayling, Michael J., Mander, Adrian P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855632/
https://www.ncbi.nlm.nih.gov/pubmed/26609689
http://dx.doi.org/10.1002/pst.1726