Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-142

That's why the GvHD decision by the FDA aggrieved me so. In typical herd mentality thinking RCT's have become the Gold Standard of medical trials to the detriment of patients in many places. The FDA flippantly gave MSB the 'adult' RCT option as if MSB was negligent in not running one already. Why are people so against kids dying over what is utlimately statisitcal theory, but okay with adults. Its particularly complicated by compassionate use.

Patient: "So let me get this correct? I can go on your trial and take a 50/50 chance at being in the placebo group and an 80% chance of being dead, but I might get on the treatment group and have an 80%+ chance of living?"

Doctor: "Yes"

Patient: "So...is there any way I can just pay you and have the treatment?"

Doctor: "Well, there is a compassionate use program..."

Patient: "Yeah, bugger the trial"

RCT's are easily done in drugs, though controlling for the 'placebo effect' is also a factor. But authorities are becoming that anal about them its recking patients lives. I have a Surgeon friend who sits on ethics commissions who increasingly has to sign off on sham surgeries. When you step back and think about cutting open ill people and doing nothing it confounds the word 'ethics'.

At least MSB won't have any 'placebo' effect in their FDA designed trial. The placebo group will mostly likely be dead.