Pazdur said:The use of external control arms in oncology is an evolving area of methodological advancement and regulatory interest. Thus far, external control data have been limited to establishing natural history or providing supportive data analyses affording clinical context for an observed treatment effect. These data have not provided pivotal support as substantial evidence of treatment effectiveness in oncology, and therefore have not yet been included in the prescription drug labeling.
this is on the article you posted. LOL LOL so perhaps one might to reconsider your statement that 45 drugs were approved using ECAs. LOL LOL
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