A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

Background: Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or to remove the drug from the market. This stud...

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Bibliographic Details
Main Author: Lexchin, J. (Author)
Format: Article
Language:English
Published: BioMed Central Ltd 2021
Subjects:
Accelerated approval
antineoplastic agent
Article
atezolizumab
bevacizumab
Canada
comparative study
confirmatory trial
Confirmatory trials
controlled study
data analysis
data extraction
drug approval
drug indication
drug information
drug marketing
durvalumab
Food and Drug Administration
gefitinib
glioblastoma
Health Canada
human epidermal growth factor receptor 2 negative breast cancer
Internet
liver cell carcinoma
melanoma
nivolumab
non small cell lung cancer
Notice of Compliance with conditions
observational study
olaratumab
oncology
Oncology drugs
pembrolizumab
soft tissue sarcoma
study design
triple negative breast cancer
urogenital tract cancer
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