A question I have in trials is whether they now have a way of differentiating PFS from pseudoprogression, so a shorter trial based on PFS would be possible, or will OS be the goal, or perhaps OS at something like 3 years, which should be enough to determine the survival benefit.
Certainly, all living patients should be tracked, but this cancer is so deadly that even at one year the difference in PFS may be clear if it's not confused with pseudoprogression.
Another consideration is, will there be a control group, or as the FDA guided in the journal article, will all get the vaccine and be compared with historical data.
Gary
Bullish
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