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Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

IMPORTANCE: The US Food and Drug Administration’s (FDA’s) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict a real clinical benefit (eg, overall survi...

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Detalhes bibliográficos
Publicado no:JAMA Intern Med
Main Authors: Gyawali, Bishal, Hey, Spencer Phillips, Kesselheim, Aaron S.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2019
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6547118/
https://ncbi.nlm.nih.gov/pubmed/31135808
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2019.0462
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