Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications

BACKGROUND. Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy’s clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. MATERIALS AND METHODS. We explored the rela...

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Vydáno v:Oncologist
Hlavní autoři: Liberti, Lawrence, Stolk, Pieter, McAuslane, James Neil, Schellens, Jan, Breckenridge, Alasdair M., Leufkens, Hubert
Médium: Artigo
Jazyk:Inglês
Vydáno: AlphaMed Press 2015
Témata:
Regulatory Issues: EMA
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC4571776/
https://ncbi.nlm.nih.gov/pubmed/25948678
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2014-0297
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