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An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate

IMPORTANCE: Approximately one-third of cancer drugs are approved based on response rate (RR)—the percentage of patients whose tumors shrink beyond an arbitrary threshold—typically assessed in a single-arm study. OBJECTIVE: To characterize RR end points used by the US Food and Drug Administration (FD...

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Publicado en:JAMA Intern Med
Autores principales: Chen, Emerson Y., Raghunathan, Vikram, Prasad, Vinay
Formato: Artigo
Lenguaje:Inglês
Publicado: American Medical Association 2019
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Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC6547222/
https://ncbi.nlm.nih.gov/pubmed/31135822
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2019.0583
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