US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis

IMPORTANCE: The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown. OBJECTIVES: To determine how often the FDA has authorized novel interventions ba...

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Detalles Bibliográficos
Autores principales: Razavi, Marianne, Glasziou, Paul, Klocksieben, Farina A., Ioannidis, John P. A., Chalmers, Iain, Djulbegovic, Benjamin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2019
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6739727/
https://www.ncbi.nlm.nih.gov/pubmed/31509209
http://dx.doi.org/10.1001/jamanetworkopen.2019.11111

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6739727/
https://www.ncbi.nlm.nih.gov/pubmed/31509209
http://dx.doi.org/10.1001/jamanetworkopen.2019.11111

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