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Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial

BACKGROUND: In recent years, an increasing number of anticancer drugs have been approved based on the results of a single-arm trial (SAT). The magnitude of the objective response rate (ORR) in SATs is important for regulatory decisions, but there has been no clear guidance specifying the degree of O...

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Detalles Bibliográficos
Autores principales: Oda, Yoshihiro, Narukawa, Mamoru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8922846/
https://www.ncbi.nlm.nih.gov/pubmed/35291959
http://dx.doi.org/10.1186/s12885-022-09383-w