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Thursday, December 16, 2021 7:40:45 PM
Progression is a surrogate endpoint meaning it can stand in for the true endpoint because it represents it very well. You see if you progressed with GBM before DCVax, one could be reasonably certain death would be knocking soon.
You can no longer assume this because the new STANDARD OF CARE can cause pseudoprogression. Anything tested on top of that SOC will have to be suspect of a progression. Now, the FDA has very standard ways to deal withthis type of confounding of variables. The first step is to look again at a later date like 3 or 6 months depending on the condition. The next is to have blinded reviewers adjudicate cases so that borderline calls can be made. That is usually a committee of 3 experts not otherwise involved in the trial.
Sound familiar….
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