Some of us think the PARTIAL Halt which allowed patients to still enroll was due to the fact that it was a placebo trial and that withholding the treatment from the placebo patients was unethical, which is a real thing that happens with oncology trials with a placebo arm, where patients are doing very well...and they knew that all the patients were living longer, in my opinion.
If the treatment had accelerated progression of what is an extremely aggressive and deadly cancer, that would have been a safety issue and the FDA would have required an updated disclosure to patients, at the least, so that they could choose to stop treatment. I believe they would have told the doctors and company and it would be necessary to disclose it to the patients. That did not happen. Instead, patients were allowed to continue in the trial and a good number completed an initial enrollment having not received any treatment.
Placebo trials are not common in oncology because of the moral issues. They are only used where expectations are that the difference between placebo and non-placebo will be very small, so you need to have the placebo arm to demonstrate the benefit. In my opinion, it became clear earlier than those on the bulletin boards today realize, to the DMC that the effect was large enough that maintaining the trial as originally planned, would be unethical for the placebo patients and could substantially reduce their survival.
That’s just my personal opinion, after much research generally on these sorts of matters with oncology trials. I could certainly be wrong and I am sure many may think I am... but that’s my view as a strong possibility and I think stronger than the reasons generally proposed. Again, just my opinion. The improved survival is striking, and there were unblinded arms too, for patients who did not qualify for the trial. Those patients did very well and it was known early on, the treatment was recognized in the UK as a very innovative treatment, because patients were doing so well.
But, you still have to successfully complete a trial like this and let the data evolve over a reasonable amount of time to demonstrate the apparent efficacy and the DMC and regulators are the only parties that can officially know what causes such a halt, so that the trial can proceed on an orderly basis. Company officials are never notified. That is a kind of hard indicator though of what may be occurring when you see these kinds of facts... it was definitely not a safety issue. Most theories proposed are, in my view, inconsistent with the facts as observed, in reality, not in billboard land. Land where people must argue with shorts who put out their own theories as the premise of every discussion on the PARTIAL halt.
Good luck. I’m no expert, but I have a strong opinion.
Quoting the very good summary but adding my difference in this point though I din’t Necessarily mean to suggest this is not what the general belief is and it’s all an excellent summary Senti... just adding my view for the person asking...
“The reason for the screening halt (which was lifted in Feb 2017) was never given but most think it was due, initially, to what appeared to be too many treatment patients eventing earlier than the the control arm patients. The ones that could see that would be the data monitoring committee (DMC) who could view the trial unblinded. Some think the DMC tried to halt the entire trial, but the company persevered claiming that all the patients were living longer, despite the early progression. One should note that the head of the DMC was also working on the scientific advisory board (SAB) of a competing dendritic cell company, and his brother was on the board of directors and SAB of the same company during the entire time, unbeknownst to anyone including NWBO. You can make of that what you will.”
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