There was no placebo arm in the Optune trial. It clearly made things easier for Optune to get approved, but left real efficacy analysis highly questionable, particularly when they did not provide real long term follow up, and it appears actual four and five year survival would have been terrible.
No, she means there was no placebo control. As in; there was no sham device for control arm patients. It was open label. Control arm patients knew from the get go, that they were not getting the investigational treatment. All adds to the bias. This was the underperforming control arm, which made it easy for the treatment arm to show apparent superiority.
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