4 ms·
I would go farther than that. I think the FDA has to interpose itself between the drug developer and the entity doing the study. The developer should provide
by ScottBurson 14y ago
I would go farther than that. I think the FDA has to interpose itself between the drug developer and the entity doing the study. The developer should provide a sufficient amount of the drug to do the study, and write a large check. Everything else should be handled between the FDA and the university or whoever it is doing the study; the latter should have no contact with the developer. Ideally, the drug developer and the university should not even know each other's identities. The university would be answerable to the FDA for the quality of its work and to no one else.
I don't see any solution short of doing this. A study can't be considered truly blind unless the study design itself is done by researchers who do not know the "desired" outcome.