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Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs

OBJECTIVE: To determine the strength of the surrogate-survival correlation for cancer drug approvals based on a surrogate. PARTICIPANTS AND METHODS: We performed a retrospective study of the US Food and Drug Administration (FDA) database, with focused searches of MEDLINE and Google Scholar. Among ca...

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Detalhes bibliográficos
Publicado no:Mayo Clin Proc
Main Authors: Kim, Chul, Prasad, Vinay
Formato: Artigo
Idioma:Inglês
Publicado em: 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5104665/
https://ncbi.nlm.nih.gov/pubmed/27236424
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.mayocp.2016.02.012
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