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Small Leaps or Giant Steps
Gottlieb points out that calls for more "comparative studies" between new medicines and older drugs misses the clinical differences that are relevant to real world patients:
This mandate for "comparative effectiveness" studies, where new drugs are compared to old drugs, is a standard that is used in Europe. But the European data generated from these kinds of head-to-head trials are often ignored by clinicians here, who argued to me when I was at the Food and Drug Administration that head-to-head trials are often underpowered and therefore do not take full stock of subtle but clinically important benefits such as improved dosing schedules that lead to better compliance or better side-effect profiles, which, in turn, allow safer administration of medicines.
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