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Tuesday, March 24, 2020 1:55:08 PM
I assume that she is talking about the percent of patient who elected to use Optune off label after being assigned to placebo. Well, that is not a design issue. a patient can always elect to break protocol for an alternative treatment if the want. That is really a basic right. And Optune was already on the market so any patient was free to use it.
So not a design issue at all, just a fact of life that always makes it harder to show OS in front line when the drug is already approved.
Now, if she is talking about the confounding effect, yes it happens. Optune showed P < .05 despite it.
Maybe we will know DCvax-L results by next ASCO (which I expect in 2021).
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