By phase 3 they should have to preregister the study and identify the outcomes they will measure. There isn't much room for p-hacking at this point.
There will certainly always be bias, but it's still a gold standard for good reasons.
There will certainly always be bias, but it's still a gold standard for good reasons.
Not all Phase 3 with negative outcomes are published. It's actually the opposite. Most of them are not. So preregistration achieves nothing in terms of transparency.
And p-hacking still happens far more often than you think - I have personally seen trials where they identified "sub-groups" of patients in order to prove that there were patients for which said drugs worked. That's a thing, no matter what you decided to set in the first place as objective.
And then there's stuff like Biogen's alzheimer drug for which no efficacy was proven but still received FDA commercialization approval. Everything is working just peachy, right?
What does this mean exactly? Is it the best possible? Or the best available?
If it is the latter, then it does not mean much. If it is the former, then your statement is not true.