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Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

BACKGROUND: In July 2018, the FDA first published a table listing all surrogate measures that it has used, and may accept for future use, in regulatory approval. However, the strength of surrogacy for those measures was not formally assessed. Using the case example of breast cancer, we aimed to eval...

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Detalhes bibliográficos
Publicado no:EClinicalMedicine
Main Authors: Gyawali, Bishal, Hey, Spencer P., Kesselheim, Aaron S.
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7201012/
https://ncbi.nlm.nih.gov/pubmed/32382717
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.eclinm.2020.100332
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