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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Detalles Bibliográficos
Autores principales: Gyawali, Bishal, Hey, Spencer P., Kesselheim, Aaron S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Research paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201012/
https://www.ncbi.nlm.nih.gov/pubmed/32382717
http://dx.doi.org/10.1016/j.eclinm.2020.100332

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201012/
https://www.ncbi.nlm.nih.gov/pubmed/32382717
http://dx.doi.org/10.1016/j.eclinm.2020.100332

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