NWBO and FDA agreed that PFS for DCVax-L is nothing compared to the "OS" results for DCVax-L. Case closed, move on since your comments and opinions are old news repeat, repeat, and repeat. Good news on the horizon and multiple changes for a number of federal agencies, IMPO.
That is a complete mischaracterization how what occurred Hy . . . complete bullshit. NWBO recognized that PFS didn't work as an end point a decade ago soon after the trial started and they saw tumors increase in size initially due to the infiltration of immune systems cells killing the cancer that was being mistook for tumor Progression vs PFS.(Progression Free Survival). The trial end point shifted to overall survival and to compare to other external trial data mainly because much of the placebo control group they lost or was corrupted by the crossover provision where they could crossover after Progression so Overall Survival would be altered (bettered due to DCVAX) The modification to the endpoints where made before any trial data was visible to them.
By itself, an endpoint modification is not problematic because a clinical trial is a coalescence of ideas and midstream changes. However, a noted change in and of itself raises a perception of bias in an active trial that is open and accruing and even more so in a trial that has completed accrual.
By itself, an endpoint modification is not problematic because a clinical trial is a coalescence of ideas and midstream changes. However, a noted change in and of itself raises a perception of bias in an active trial that is open and accruing and even more so in a trial that has completed accrual.