With the prospect that innovative drug therapies will be introduced in the coming years, society demands new approaches and concepts for comparative risk/benefit evaluation. Those evaluations will be carried out once these therapies have been used widely in daily practice. Comparisons of the risk and benefit of different drug therapies will be done in the framework of observational epidemiological studies (proof of 'safety', proof of 'effectiveness'). This is the logical next step after randomized clinical trials, which are designed to provide evidence of a drug's 'efficacy'.
Pharmacoepidemiology and Clinical Pharmacology
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