"If I recall correctly, there is a statistically significant correlation to OS based on whether there is early psPD or later psPD. This may be the rational for earlier screening vs. standard procedure as the Phase 3 trial focuses on eliminating the outliers. This may also explain why there was only one psPD found in the expanded access trial." Doc logic
Where did you hear about the SS correlation for early vs later psPD? I'd love to see the source of that info. In regards to this p3 trial, imo it doesn't really matter for the main trial when the screening out for rapid progressors occurred because the net effect should be balanced between the two arms. It will matter for the ease of meeting the 32 psPD patients needed for the psPD arm randomized study because IMO based on the info arm study, they will have a hard time getting 32 psPD patients due to the inadequate waiting period for the baseline 2 MRI. Makes me wonder if the DMC would be concerned by a potentially low enrollment rate for that arm. Enough to ask for a temporary halt to correct?
BTW when you state the later psPD patients, I'm assuming you are referring to those who will NOT be screened out of the main p3 trial but whose PFS determination will be in error as AVII pointed out.
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