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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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Bibliografiske detaljer
Udgivet i:Pharm Stat
Main Authors: Grayling, Michael J., Mander, Adrian P.
Format: Artigo
Sprog:Inglês
Udgivet: John Wiley and Sons Inc. 2015
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4855632/
https://ncbi.nlm.nih.gov/pubmed/26609689
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pst.1726
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