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Re: Lykiri post# 402522

Friday, 09/17/2021 10:01:38 AM

Friday, September 17, 2021 10:01:38 AM

Post# of 690870
Just a quick thought… the DCVax-L trial was truly randomized. No one knew which patient was treatment or control. And since there were very likely treatment patients who appeared to event early (due to the pseudoprogression caused by DCVax-L), it was likely even harder to tell who was who as those patients you likely have thought (initially) were control patients! Anyhow, my bigger point is that this trial was a randomized controlled trial. And so, too, were the trials from which the ECA (external control arms) that will be used to compare the DCVax treatment arm to. So the trial purists out there could/should consider that both the treatment arm and the ECAs will have both actually been drawn from fully randomized control trials… just not for the same trial. I’d think, then, that there would be little to no discoverable bias, then, as the intent had always been (at least for the full term of the trial) to not treat the treatment arm of the DCVax trial as a single arm trial.
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