Quote:
Originally Posted by Lanfear
YES!
No! If something is terrible 50% of the time that's a No. If 50% of patients have severe side effects from medicine that's not a successful trial? Please explain.
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Depends always on the primary end point of the trial, and this point is determined before the trial.
Side effects are determined on healthy individuals before it comes to the question if the medicine is really helping or not in sick people.
These are phase 1 studies.
So basically if 50% of healthy individuals had terrible side effects, there would be no phase 2 or 3 study to see if the medicine helps, the drug would be cancelled.