Will it be prior to Mittendorf's presentation? What will she say during her talk....that there was a mistake with the treatment arms in the clinical trial?? So bizarre.
Once we secure a date and time for the call we will issue a press release and provide a status update at that time.
Point well taken. They did have a discussion prior to releasing the letter. So, I guess the biostatistician recommended that systemic reversal be investigated. In that case, as intriguing.
The 5th International Inflammatory Breast Cancer Conference
Thursday, July 7 - Sunday, July 10, 2016
Long Wharf Marriott
Not aware of any public speaking since last week. It's a tricky time. It must be devastating to her. However, she's on the agenda this Thursday 8 am, Havard conference on breast cancer......giving a lecture on breast cancer vaccines. Would be nice if someone would attend and report back....
Fritsch: First, I don't believe in any conspirarcy. Pharma/interst groups would not conspire to prevent neuvax on the market. Contrary, they would jump on the bandwagon. But, that's my opinion. Second, the combo trial, open-label, and FBP, GALE-401 all have value to GALE. Mittendorf is unblinded to the open-label trial data. She continues to give her talks on vaccine and neuvax. She knows what's happening. As for the present trial, wish I knew the answers. Shocking to here the news. Here's my take: There's no way if IDMC was fully convinced the data was legite (i.e. no systemic reversal) that they would leave the door open for an investigation. They would have said STOP. That's it that's all. Stop the trial. Move on. Stop. BUT, since they left the door open, that means someone somewhere supsects something or someone convinced IDMC that something happened. I think both Mittendorf and GALE, maybe CRO?? convinced them something happened. Plain and simple. Strange. So, what are the odds of reversal.............honestly.......10%......
The other point in the letter is the urgency to conclude their investigation. Why the urgency when the trial is stopped?
Info to educate ourselves.
•allocation concealment is performed when the treatment allocation system is set up so that the person enrolling participants does not know in advance which treatment the next person will get
•it is necessary for randomisation to be successful in an RCT
•Proper allocation concealment shields knowledge of forthcoming assignments, whereas proper random sequence generation prevents correct anticipation of future assignments based on knowledge of past assignments
•Methods used for allocation concealment include sealed envelope technique, telephone or web based randomization.
•Allocation concealment ensures that the treatment to be allocated is not known before the patient is entered into the study
Allocation concealment is a different concept to blinding. It means that the person randomising the patient does not know what the next treatment allocation will be. It is important as it prevents selection bias affecting which patients are given which treatment (the bias randomisation is designed to avoid).
Allocation concealment is possible with all types of trial, including unblinded trials, and is therefore universally recommended. The best way of ensuring allocation concealment is to use a centralised service, since this cannot be subverted by investigators and provides independent verification that it was not possible for the investigators to know the allocation sequence in advance.
by C.K? (appologize to the author, lost the link).
Indeed. I strongly believe they had no choice but to stop for safety (and liability) reason. BUT, the committee had to be convinced, the biostatistician had to agree or even suggest. Something was off. They will likely have to review randomization of the 750 patients. Maybe they had to get the FDA involved? Turn of events.
Must add, they will look at blood work/surrogate markers/ antibody to help confirm randomization. Un blinding happening as we speak......
According to a typical charter of IDMC (see my previous FDA link):
GALE, IDMC, Mittendorf (they) most likely participated in all of the open meetings. The biostatistician overlooked trial procedures/randomization.
They new they had to accrue an additional 45 patients to keep statistical power.
They were able to extrapolate recurrence timelines.
The chair of IDMC had a conversation with Mittendorf and or Schwartz prior to written recommendation.
It seems to me that the results are skewed and likely significant. It seems to me that Mittendorf was able to convince the chairman and biostatistician that something went wrong. In return, instead of suspending trial, GALE agreed to stop it as if there was a systemic reversal, data compelling to halt and submit. That's the chance they are taking.