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

Internet

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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