Feasibility of Randomized Controlled Trials for Cancer Drugs Approved by the Food and Drug Administration Based on Single-Arm Studies

BACKGROUND: The US Food and Drug Administration (FDA) introduced an Accelerated Approval (AA) pathway to expedite patient access to new drugs. AA accepts less rigorous trial designs, including single-arm studies (SAS), owing to perceived lack of feasibility of timely randomized controlled trials (RC...

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Detalles Bibliográficos
Autores principales: Rittberg, Rebekah, Czaykowski, Piotr, Niraula, Saroj
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8364671/
https://www.ncbi.nlm.nih.gov/pubmed/34409254
http://dx.doi.org/10.1093/jncics/pkab061

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