Food and Drug Administration approvals in phase 3 Cancer clinical trials

Food and Drug Administration approvals in phase 3 Cancer clinical trials

Abstract Background Phase 3 oncologic randomized clinical trials (RCTs) can lead to Food and Drug Administration (FDA) approvals. In this study, we aim to identify trial-related factors associated with trials leading to subsequent FDA drug approvals. Methods We performed a database query through the...

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Bibliographic Details
Main Authors: Joseph Abi Jaoude, Ramez Kouzy, Marc Ghabach, Roshal Patel, Dario Pasalic, Elie Ghossain, Austin B. Miller, Timothy A. Lin, Vivek Verma, C. David Fuller, Vivek Subbiah, Bruce D. Minsky, Ethan B. Ludmir, Cullen M. Taniguchi
Format: Article
Language:English
Published: BMC 2021-06-01
Series:BMC Cancer
Subjects:
Oncology
Clinical trials
FDA
Primary endpoint
Surrogate endpoint
Industry
Online Access:https://doi.org/10.1186/s12885-021-08457-5

Internet

https://doi.org/10.1186/s12885-021-08457-5

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