Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021

This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.

Detalles Bibliográficos
Autores principales: Deshmukh, Anjali D., Kesselheim, Aaron S., Rome, Benjamin N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10066454/
https://www.ncbi.nlm.nih.gov/pubmed/37000434
http://dx.doi.org/10.1001/jamahealthforum.2023.0217
Descripción
Sumario:This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.

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