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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Elsevier
2020
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| 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 |