exwannabe,
You appear to me to be a very knowledgeable person with regards to drug trials and the associated statistical methods and because you are willing to share that knowledge with us (for which I am grateful; no joking here) I would like to get more in depth with you regarding your statement about the 6 patients who "vanished" in the first few months.
You have stated that if they had actually died there would be no OS benefit.
It is my understanding that these patients left the treatment process early (for what could be a myriad of reasons, including death) and were unable to complete the treatment regimen and therefore were "censored" by an independent board of physicians trained, licensed and specializing in determining "censor" status for studies like this. I'll be calling them the censoring board for this discussion if you don't mind.
Would not the censoring board make the determination that these patients did not participate in enough treatment cycles for their data to be relevant to the study?
Wouldn't it be expected in a trial for a severe disease like 2nd line NSCLC that there would be some patients so far gone by the time they started this last ditch treatment that they would be expected to expire very early on in the treatment cycles that it would be appropriate to not count them as part of the trial data?
Would it not also be expected that people change their mind and decide they don't want to continue with anymore treatment due to side effects of chemo and live out their remaining days w/o having to suffer the effects of the treatment along with the disease effects?
Isn't this censoring process part of all trials with guidance provided by the FDA on how to censor?
Also, and what I believe is very important, in the case of a double blinded trial like Peregrine's 2nd line NSCLC trial, it is my understanding that Peregrine personnel have absolutely no say in the censoring process and this process is completely in the hands of a licensed group of physicians contracted to make these determinations. Is this correct or am I missing something here?
Having said all this, it is my understanding that these 6 patients that were censored were part of a standard trial process that all trials use and this process was out of the hands of Peregrine, so why do you keep bringing this up?
It may be my imagination but, it seems that you are trying to project a thought process that there is something very out of the ordinary and very suspicious here with the 3mg arm data relative to these censored patients.
You have on more than one occasion brought up this point about these early censored patients so that is why I'm trying to get more info from you on this point.
Do you have more information that could be helpful in understanding why we should be suspicious of this data; why should we believe that Peregrine's data should be considered to have been generated from a "rigged" process that is not representative of processes sanctioned and recognized as appropriate by the FDA?
This isn't a trap and I'm not trying to catch you in anything. You appear to me to be very well informed in these matters and I would like to get your in depth input on this issue as I believe it is extremely important to have "faith" in this 3mg arm data as it is the foundation of my position in this company. I too like to see all views too when they are not obvious and constant bashing.
Thanks in advance for your time and input on this issue.
