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Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

OBJECTIVES: To investigate the regulatory handling of cancer drugs that were granted accelerated approval by the US Food and Drug Administration (FDA) but failed to improve the primary endpoint in post-approval trials and to evaluate the extent to which negative post-approval trials changed the reco...

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Detalles Bibliográficos
Autores principales:	Gyawali, Bishal, Rome, Benjamin N, Kesselheim, Aaron S
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group Ltd. 2021
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424519/ https://www.ncbi.nlm.nih.gov/pubmed/34497044 http://dx.doi.org/10.1136/bmj.n1959

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