Monday, February 22, 2016 7:04:31 PM
Still unclear what happens when a treatment arm patient 'crosses over'.
Do they 'reset the clock' or just continue dosing regimen? (I'm unclear). Do they employ placebo at all after crossover? --- longfellow95
In order to maintain the blind, it is my understanding that when a patient progresses & accepts the crossover option ... that they do start their treatment protocol as if they were back at day one.
If they only did this accelerated protocol with a patient that crossed over from the placebo arm, but not for a patient that crossed over from the treatment arm, then the doctors & patients would quickly realize which arm they were in prior to crossing over. In order to keep the blind, they start all patients at the beginning of treatment protocol after crossing over.
So they 'do not just continue dosing regimen", but instead "reset the clock" (to put it in your words).
Do they employ placebo after crossover?
First part of the answer would be that they do not employ the placebo IMMEDIATELY after crossover. Instead, they inject the real vaccine immediately after crossover .... until the patient has no remaining real vaccine left over for injections.
This is of course less likely to happen to a patient who crossed over from the placebo arm, since he/she would not have used up any of his/her real vaccine yet.
It is my understanding that a patient who starts in the treatment arm, and then progresses, and then accepts the crossover option, and continues to receive his/her real vaccine until it runs out .... I get the impression that for this patient it might hold true that he/she winds up possibly getting some placebo vaccine at the tail end of the trial to maintain the blind.
Up to the 3 year mark, I believe.
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