> You are aproaching it as if the question we are asking is if this is the best study design. But that is not the question we are asking. There is a patient who we believe is about to die soon. In comes a drug manufacturer and says to the patient: “you do not have to die. I think I have the cure for you”. The patient wants the drug the drug manufacturer is offering. The question is if we are to interject and stop the drug manufacturer giving the patient the drug, and if so under what circumstances.
This is already largely possible in most states and called "right to try".
> Do I understand you right?
No you seem not to be. Giving away drugs is fine and largely already possible. Choosing patients and then pretending that the data gathered has any reasonable statistical validity when considering general approval of a drug is totally crazy. I think there is essentially zero chance the FDA would ever go for an idea with such overt conflicts of interest so I'm happy your idea will never turn into reality.
> This is already largely possible in most states and called "right to try".
The article’s author is convinced it is not covering them. Do you know otherwise? Perhaps you should let them know. You might save a life.
> Choosing patients and then pretending that the data gathered has any reasonable statistical validity when considering general approval of a drug is totally crazy.
Would like to mention that it is your adition that the drug manufacturer chooses the patients. It was not part of my original comment. And it is not core to the idea.
One can simply imagine a protocol where the manufacturer declares their criteria (what condition, what severity[1]) and how many doses they are able to provide and those “places” get filled up with volunteers. And this of course can be made even more buletproof.
1: and before you point it out, of course if the manufacturer is only willing to test their drug on not-so-bad-but-dying people then they get approval to be used on the same selection.
This is already largely possible in most states and called "right to try".
> Do I understand you right?
No you seem not to be. Giving away drugs is fine and largely already possible. Choosing patients and then pretending that the data gathered has any reasonable statistical validity when considering general approval of a drug is totally crazy. I think there is essentially zero chance the FDA would ever go for an idea with such overt conflicts of interest so I'm happy your idea will never turn into reality.