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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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Detalhes bibliográficos
Publicado no:Oncologist
Main Authors: Liberti, Lawrence, Stolk, Pieter, McAuslane, James Neil, Schellens, Jan, Breckenridge, Alasdair M., Leufkens, Hubert
Formato: Artigo
Idioma:Inglês
Publicado em: AlphaMed Press 2015
Assuntos:
Acesso em linha: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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