Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–2020

Real-world evidence (RWE) has garnered great interest to support registration of new therapies and label expansions by the United States Food and Drug Administration (FDA). Currently, practical insights on the design and analysis of regulatory-grade RWE are lacking. This study aimed to analyze attri...

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Detalles Bibliográficos
Autores principales: Arondekar, Bhakti, Duh, Mei Sheng, Bhak, Rachel H., DerSarkissian, Maral, Huynh, Lynn, Wang, Kelsey, Wojciehowski, John, Wu, Melody, Wornson, Bryon, Niyazov, Alexander, Demetri, George D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Association for Cancer Research 2022
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401526/
https://www.ncbi.nlm.nih.gov/pubmed/34667027
http://dx.doi.org/10.1158/1078-0432.CCR-21-2639

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401526/
https://www.ncbi.nlm.nih.gov/pubmed/34667027
http://dx.doi.org/10.1158/1078-0432.CCR-21-2639

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