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flipper44

06/15/19 7:43 PM

#233421 RE: Lykiri #233416

In other words Dr. Bosch has been recounting the history of the trial from 2008 (not 2010) to 2011 correctly, but Dr. Liau has not.

meirluc

06/15/19 9:55 PM

#233435 RE: Lykiri #233416

Yes Lykiri you are right. The enrollment curve shows that about 17 patients were enrolled by about April 2009 and that no additional enrollment occurred until about August 2011. I certainly knew this years ago and had forgotten it since.
Lesson learned: It is worthwhile from time to time to review past presentations, curves etc.

I am just wondering how many of the very early enrolled 17 were patients who were enrolled in the treatment arm before the start of the randomization process. I am guessing that if any such patients remained in this trial, it could not be more than a handful.

That makes me feel better because had the overwhelming majority of the 38 patient vanguard been assigned to the treatment arm, it would have been hard to explain the dismal survival results demonstrated by this group. The only time that would make sense is if placebos turn out to have a better survival record than treatment patients and that is unlikely.

That still leaves unexplained how in a trial supposedly randomized 2 treatment patient to every placebo, we ended up instead with a 2.3:1.0 ratio.