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Posted On: 02/24/2021 1:58:43 PM
Post# of 148872
Hi Bridge to Sell--
In your post you address one of the few nagging issues I have about the CD12 trial, the lack of a survival benefit in the placebo arm due to the improved standard of care in the second half of the trial.
Your point makes complete sense--that Dr Agresti , with his experience with LL, suggested to doctors at the clinical trial sites to use the drug on more critical cases, and thus the more critical population had more deaths even though the SOC improved.
I am curious though... I wasn't aware Agresti visited the clinical trials in the fall. Later you mention Agresti is credited with "single handedly filling up the second half of the trial and getting us to full enrollment." But I thought Brian Brothen was the CYDY enrollment specialist who is generally credited with getting the trial filled so expeditiously in the fall.
I'm kinda like Colombo--I like to figure out the loose ends. I'm curious if you can clarify any of this. I know Agresti is very supportive of LL but I don't recall anything about him going on the road as a consultant.
As far as the lack of a noticeable effect in the trial numbers due to an improved SOC, the only thing I came up with is that some of the trial sites were getting pretty busy in late Nov and Dec, and we know deaths in the ICU go up when they get crowded. I would imagine both points--a more critical trial population, and more crowded conditions, probably explains the conundrum.
Anyone else like to weigh in? Any other explanations out there?.
In your post you address one of the few nagging issues I have about the CD12 trial, the lack of a survival benefit in the placebo arm due to the improved standard of care in the second half of the trial.
Your point makes complete sense--that Dr Agresti , with his experience with LL, suggested to doctors at the clinical trial sites to use the drug on more critical cases, and thus the more critical population had more deaths even though the SOC improved.
I am curious though... I wasn't aware Agresti visited the clinical trials in the fall. Later you mention Agresti is credited with "single handedly filling up the second half of the trial and getting us to full enrollment." But I thought Brian Brothen was the CYDY enrollment specialist who is generally credited with getting the trial filled so expeditiously in the fall.
I'm kinda like Colombo--I like to figure out the loose ends. I'm curious if you can clarify any of this. I know Agresti is very supportive of LL but I don't recall anything about him going on the road as a consultant.
As far as the lack of a noticeable effect in the trial numbers due to an improved SOC, the only thing I came up with is that some of the trial sites were getting pretty busy in late Nov and Dec, and we know deaths in the ICU go up when they get crowded. I would imagine both points--a more critical trial population, and more crowded conditions, probably explains the conundrum.
Anyone else like to weigh in? Any other explanations out there?.
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