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Tuesday, February 05, 2019 1:43:43 AM
But if you want experts, and you are going to look at the whole clinical picture, you need to review the whole clinical record.
Obviously, the post 'progression' scans would be an important part of that, but wouldn't give the whole picture.
I think you would need 3 as you say. A radiologist or perhaps two with acknowledged expertise in recognising pseudo-progression for what it, and probably a senior neuro-oncologist as well. Three would allow for a casting vote just like with central review. The likelihood of finding them available in the same location, and all able to devote an intensive chunk of time might be slim. So, I do think it would be a lengthy procedure over many sessions. There will hopefully be 30 or 40, who have never been deemed to have progressed, and thus not requiring adjudication.
And I hope my concern is not justified. They might have completed the process, or be 90% there. Thus no further delay.
But I'd feel a lot happier if they told us that.
I can see why they might be reluctant to draw much attention to it though, because naysayers will make a big play about it. You know the sort of stuff that might be said.
It's just that there has been so much uninformed speculation about timescales to unblinding, and how long it takes to write an SAP: speculation which, to me, was disregarding a factor that may greatly affect that timescale.
So, I've expressed my concern about it once, but I certainly won't keep banging on about it!
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