Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval

This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and...

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Detalles Bibliográficos
Autores principales: Wallach, Joshua D., Zhang, Audrey D., Skydel, Joshua J., Bartlett, Victoria L., Dhruva, Sanket S., Shah, Nilay D., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579227/
https://www.ncbi.nlm.nih.gov/pubmed/34751763
http://dx.doi.org/10.1001/jamanetworkopen.2021.33667
Descripción
Sumario:This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018.

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