However, it has been recognized for some time that the ability of suc
h highly controlled clinical trials to predict the true benefit-to-harm profile of the medicine may be very limited, and that is because clin
ical trial evidence does not allow anyone to really see across the entire patient horizon — that is to say, to see the benefit or harm that may be ob
served in the total population of patients who will sub
...[+++]sequently be exposed to the medicine outside the controlled clinical trial environment.