Monday, February 20, 2023 2:51:25 PM
This is verifiably false.
“Clinically appropriate” means that the trial treated the human participants as human and not as lab rats.
Regarding the landmark P3, the FDA would argue that the GBM patients were not lab rats, and the crossover design was necessary.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
If you like traditional placebo trials, then you’ll love the PD1 combo trial. This trial doesn’t require crossover because all of the placebo participants have access to an efficacious therapy (100% of the placebo control group are receiving DCVax-L):
https://clinicaltrials.gov/ct2/show/NCT04201873
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
“Clinically appropriate” means that the trial treated the human participants as human and not as lab rats.
Regarding the landmark P3, the FDA would argue that the GBM patients were not lab rats, and the crossover design was necessary.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
If you like traditional placebo trials, then you’ll love the PD1 combo trial. This trial doesn’t require crossover because all of the placebo participants have access to an efficacious therapy (100% of the placebo control group are receiving DCVax-L):
https://clinicaltrials.gov/ct2/show/NCT04201873
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Bullish
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
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