Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned

Despite increasing utilization of real-world data (RWD)/real-world evidence (RWE) in regulatory submissions, their application to oncology drug approvals has seen limited success. Real-world data is most commonly summarized as a benchmark control for a single arm study or used to augment the concurr...

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Detalles Bibliográficos
Autores principales: Ro, Sunhee K., Zhang, Weidong, Jiang, Qi, Li, Xiaoyun Nicole, Liu, Rong, Lu, Chengxing Cindy, Marchenko, Olga, Sun, Linda, Zhao, Jing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276785/
https://www.ncbi.nlm.nih.gov/pubmed/37179264
http://dx.doi.org/10.1007/s43441-023-00528-y

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