Ok. I can't believe I'm walking people through this again. There has NEVER been a drug approved for use on 80% CI while a clinically safe and efficacious treatment is available. You use an 80% confidence interval if you are trying to get something approved in a jurisdiction that has lower regulatory standards (and lower cancer market values) or if you are concerned about your drug not being very good.
From the CONSORT guidelines: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398298/pdf/SJA-13-27.pdf
I shoudn't need to explain to you what the CONSORT guidelines are, right?
Ok, it's quite clear you do not get what I am saying, so let's demonstrate the weakness of these models another way. Let's look at a Checkvacc mouse model example where there is pretty clear in-human data that supports the weakness. The issues with the mouse models below are that they are 1) weak; 2) dosed 1 day after tumors were engrafted; and 3) non-significant (0.049[marginal] and 0.053) TO PBS. There is no significant difference between the CF33-pd1 combination and single agent CF33 or pd1. The only way the researchers can get a significant difference TO PBS is by injecting the anti-pd1 intratumorally (2nd image), but once again dosed the day after tumor engraftment. PBS is saline solution...
Triple negative breast cancer patients are extremely difficult to treat, so you want to use in vivo models that replicate this and/or have methodology that allows the aggressiveness of the cancer to mature - maybe waiting 7-days for the tumor to grow before you treat. This is not the first time I have highlighted this for IMUs mouse models.
How did this translate to triple negative breast cancer patients? 6 patients evaluable, 5 progressive disease and 1 stable disease.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051185/pdf/koni-09-01-1729300.pdf
https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/6392686e3b79462db75f4edb/1670539377946/21094+SABCS+2022+11-11-22.pdf
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Ok. I can't believe I'm walking people through this again. There...
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