Hi DMB,
No, it’s standard to discuss GBM overall survival times from the time of surgery on all GBM treatments. They simply deducted the “time to treatment” variable, which I believe in this study was referred to as 3.1 months, in order to have a comparable yardstick to measure survival times against other GBM treatments. They did the same thing on their other phases studies as well when discussing overall survival. It’s simple the way the industry speaks about GBM treatment, as at the end of the day when either scientists or regulators compare DCZvax-L to other treatments they will do so not from the survival time of first injection but instead from the initial GBM surgery.
Treatment start times do not change. The active phase of this trial from when treatment starts remains 36 months. The protocol lists it as such. As do study consents. Nothing about the protocol treatment scheduled changed when the trial resumed in 2014. The only thing that changed was the statistical analysis plan.
“The Company has been blinded at all times, with no access to any data in the Phase III trial, and WILL REMAIN FULLY BLINDED UNTIL THE TRIAL IS COMPLETED. The changes relate to the statistical analyses that WILL BE DONE AT THE END OF THE TRIAL be done at the end of the trial, and do not affect the treatment protocol, dosing, randomization of patients or other such aspects.” August 2014 PR
The Phase III consent form also makes it very clear that the active trial phase is 3 years.
“The clinical trial will consist of three phases: the initial evaluation phase (also known as the screening phase), the active treatment phase, and the follow-up phase. During the evaluation phase you will undergo some testing noted below to indicate whether you can participate. The next phase, the active treatment phase, is when patients are treated with DCVax-L or placebo. During this phase, which lasts up to 36 months, you will be asked to return to the clinic once every two months for MRIs and other tests as outlined below under Study Visits Procedures to determine how you are doing. During the follow-up phase, which starts after the 36 months is completed or after you leave the trial for any reason, you and/or a designated contact will be contacted every third month to collect medical history including data on long-term progression or re-growth of your brain cancer as well as survival data.. Please read the section titled Follow-Up Information.”
