LL, The point your missing, deliberately or mistakenly, is that the final result statistics are not representative of what happened in the real world. Really? Because that's exactly what the three phase trial is supposed to represent, namely what is likely to happen in the real world.
Statistically, if there is even an 0.1% chance of an adverse reaction to a drug when measured across the general population, that would definitely be discovered during Phase III.
More likely to slip through the cracks, however, is if there is a chance of an adverse reaction in a certain group of patients with a given "pre-existing condition." But even then, a Phase III trial has a good chance of discovering those interactions.
If you don't believe in the three phase standard, that's fine. Maybe you can make a good argument against it, publish a paper, and if you succeed in changing that standard and saving lives, you could be awarded the Nobel Prize in medicine.
I'm willing to bet that you won't, however.
Tenchusatsu |
