Thursday, May 11, 2023 1:44:34 PM
From the links provided:
Hardly sufficient patient level data.
prognostic biomarkers,
Patient selection total different especially by including low life expectancy of biopsy only patients when the trial required GTR.
I could go on and on but this literally took me a minute from one of the supplied links.
None matter as using an ECA needs to be specified in the design process, not the cover ones ass from the crappy data process.
An external control arm data source should be temporally and clinically relevant to the investigational arm to minimize bias, and necessitates sufficient individual patient-level data to ensure a well-powered comparison.
Hardly sufficient patient level data.
The same data may have disadvantages, however,
such as being temporally irrelevant with respect to patient selection,
Patient selection total different especially by including low life expectancy of biopsy only patients when the trial required GTR.
I could go on and on but this literally took me a minute from one of the supplied links.
None matter as using an ECA needs to be specified in the design process, not the cover ones ass from the crappy data process.
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