I have a few nagging questions and maybe someone can help me out. The company has twice reported on data between the control arm and the test arm. They were able to tell you in September precise treatment arm allocations based on PFS! (not tumor response) and give the n's for each arm and again in December they gave you unblinded results based on the 6 week scan. So the blind has been broken by someone, (at least twice) otherwise it would not be possible to provide TEST and CONTROL arm data and, the company has access to "blinded" clinical results at all times. They are "blinded' ONLY as to the treatment arm assignments.( I put this in here for those who don't know even that much). So how blind can you be when you have:
a) access to all clinical results on (essentially) a real time basis.
b) access to comprehensive unblinded (to someone) PFS results on the first 80 pts.
c) access to precise unblinded ( to someone) results on tumor response.
How hard is it for ONCY to make verrrrrry good estimates on PFS and OS on a real time basis given their real time access to the clinical results and having the benefit of two massive peeks at UNblinded data? They go to great lengths to tell you who hasn't seen the dat but who exactly has seen the unblinded data. That info is not clear from any of the press releases (especially the PFS data announced in September)
In addition, blinding doesn't really make any difference from a trial standpoint, since this trial is only a Phase II. You can be sure the FDA doesn't care whether the results are blinded or unblinded at this point and OS doesn't need a blind as long as the original assignments were blinded at trial inception. So why not break the blind right now? No one seriously doubts that they have iron clad PFS data and could release it tomorrow and only the most pollyannish think they don't have median OS data too. Not to put too fine point on it but these are people half of whom who were supposed to be DEAD in 150 days
rt11: You seem to be pleading with us to take you seriously. If that's what you want then the first thing that you need to learn is that the classification of a clinical trial as phase II or phase III has everything to do with the size, purpose and design details of the trial, and very little to do with the results of the trial or if that trial is going to be pivotal to the registration process.
For example, ZIOP recently announced that their phase III palifosfamide trial was not stat sig. (Google: Ziopharm Blows Up On Sarcoma Drug Failure.) So, obviously that trial is not going to be used in support of registration of pailfosfamide by the company. Did it suddently become a phase II trial? No, it is still called a phase III trial, albeit a failed phase III trial, contrary to your usage.
Your childish insistence that you be allowed to redefine the meaning of "phase 2" and "phase3" to suite your agenda is a non-starter for some of us. If you want to have an adult conversation, use the adult meaning of those words. If you want to play childish games and create your own make-believe language for clinical trials, you are going to be ignored in any serious conversations.
Sentiment: Strong Buy
The September announcement reported on the locoregional and mets only groups. There was no data on PFS for treatment arms or control arms. We know the treatment and control arms were balanced.
The December data was unblinded by tumour type, not by patient. Metastatic tumours responded better to treatment than to the control, and the effect was not as strong for primary tumours.
The final unblinding will be by patient and has not happened yet.
Of course the data on the control and the test arms was reviewed by someone -- and it was BAD so they didn't release it. The data was unblinded ( to someone, prolly the DMC) as part of the trial protocol in order to adjust the enrollment (or suspend for FUTILITY or outrageous success,) which is part of any adaptive trial. They know that the trial FAILED or else they would have announced trhe additional enrollment. End of story. Only after the dreaded "sub group analysis" and frantic sprint to the FDA did they revise the trial into 2 trials (one already DOA). Had they not done so they would have had to announce that NO number of additional trial participants would enable them to reach stat-sig. I don't believe you are a scientist.
In a "double blind" clinical trial, neither the patients nor the researchers know who is in the control group or who is in the active group. No one knows who is getting what treatment. And contrary to what you state, the ONCY Phase III remains blinded. Read the press releases and listen to the conference calls before you make a bigger fool of yourself.
From ONCY's December 13, 2012 Press Release:
"To the best of our knowledge, this is the first successful double-blinded randomized data from a clinical study using an intravenously-administered oncolytic virus. We are delighted to have obtained statistically significant data for REOLYSIN in a randomized clinical setting," said Dr. Brad Thompson, President and CEO of Oncolytics. "We continue to await the data for the other endpoints of this study, to which all parties still remain blinded at this point."
'In addition, blinding doesn't really make any difference from a trial standpoint, since this trial is only a Phase II'
Rat, we all get hat you want to change the rules to fit your agenda. But, like it or not, this is an adaptable
Phase III, not a Phase II.
stb99999ou are absolutely right.
If rat (the grifter) is actually thinking that it (H&N) is a Ph. II. he and his followers may be in for one huge and shocking surprise, because as a Ph. III it is also a registration trial.
Further, BT is not likely to announce any related registration filing because registration filing is a normal and expected consequence of such a trial.