Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study

BACKGROUND: The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product’s actual clinical effect. This study aims to compare the trea...

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Detalles Bibliográficos
Autores principales: Wallach, Joshua D., Ciani, Oriana, Pease, Alison M., Gonsalves, Gregg S., Krumholz, Harlan M., Taylor, Rod S., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863466/
https://www.ncbi.nlm.nih.gov/pubmed/29562926
http://dx.doi.org/10.1186/s12916-018-1023-9

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863466/
https://www.ncbi.nlm.nih.gov/pubmed/29562926
http://dx.doi.org/10.1186/s12916-018-1023-9

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