2 ms·
I meant “trials for research studies” as opposed to “trials for drug or device approval.” The amount of record keeping and oversight of a drug approval trial i
by gumby 3y ago
I meant “trials for research studies” as opposed to “trials for drug or device approval.”
The amount of record keeping and oversight of a drug approval trial is enormous (and as a consequence insanely expensive) — data handling, having disjoint groups at each stage handling and analyzing data, etc and detailed records of every manufacturing step — think ISO9000 on steroids.
Nobody would bother to go to that effort for a scientific exploration, nor should they. So the bar is much lower.
I am making no excuse for shoddy science! But it is quite unlikely for a licensed drug.