The blind is executed by the CRO, not the enrolling or evaluating physicians as you contend. Physicians actually do not know when they progress whether or not they had been on placebo and NEITHER DOES ThE COMPANY. Both are blind… that is what blind means. How do they execute a trial and stay blind…a CRO keeps the blind.
No more placebo means no more placebo. It is not ethical to commit a patient to death. Halt was recommended, but company chose to proceed.
You have no idea how censored but not progressed patients get handled. It presents quite the dilemma. But you do know that they stay in the combined OS KM curve. It is what you do about separating them. Isn’t it curios that PFS was not addressed in any of the refresh data release?
How do you protect patients from potentially unnecessary morbidity and mortality, and at the same time deal with the fact that ITT has a knowingly and deliberately tainted population, and per protocal eliminates many patients thus destroying power. Perhaps, you consider an external control or a hybrid external control. Hmmmm….
Patients consented to knowing they may receive active treatment that is why they entered the study. Hoping to be randomized to DCVax. They understand that per study they may receive treatment. No new consent required.
PFS was monitored in aggregate as far as any of us know. I have not seen KM analysis of Progression. If they did not progress after receiving DCVax or progressed slowlly, it is likely One reason it took so damn long to reash 248 events. KMs seen are Just for survival which was grouped. However, since we received two points in time, it can be analyzed to demonstrate 3 year survival in a cohort of about 100 patients treated with DCVax before progression. This comes to about 38% 3 year survival and about 21-24% 7 year survival in treated patients.
Officially, NWBO does not know the placebo cohort was destroyed, at least before SAP was NOT REJECTED BY FDA, that is as close to approved as you can get from FDA. This is why they cannot update US Clin Trials.gov.
FDA has published a viewpoint on ECA and HCAs.
