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09/19/17 8:40 AM

#134965 RE: iclight #134957

Please note she indicated her concern for not seeing a separation between the arms in overall survival in October 2015, two months after the halt. By December 2016, she indicated a wish that they could make a historical comparison of the OS patients as it seemed that would solve all problems. And about a month later, the halt on screening was lifted.

PFS can measure the separation between the two arms as there is no confoundment. OS can be measured as a single arm against historical controls. Of course, that would have required some changes to the trial. And time. Perhaps in time, Linda Liau's wishes were granted.
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flipper44

09/19/17 9:22 AM

#134987 RE: iclight #134957

So certain you are. She was blinded. She found that everyone seemed to be living longer than expected. She guessed there might be some crossover confoundment, but you keep taking that to the extreme. She hypothesized that there could be some possibility that too many psPD were kept out of the trial. However, you should note that living longer and less psPD are inconsistent, which should tell you that there could be a very real therapeutic effect. You don't realize that 83 progression free by November or later is simply impossible had the patients all been treated with standard of care. In fact such a proposition is ludicrous. The problem for trials with no crossover is they are unfair to patients if the therapy works.

Even if the results are significant for OS, you'll forget in a flash what she said and report as if there was no crossover. You'll belittle any results even if PFS ends up SS and OS is leaning positive, because, well, that's what you do. Know this, if this trial turns out to have Statistically significant PFS and positive (or Stat sig) OS, it's in spite of the crossover, and the results would have been much more impressive without it, but then again, those are sacrifices made for compassion.