[Benefits and harms - two sides of the same medal?].

Efficacy, efficiency, value, and harm constitute the terminology that is used to decide about drug licensing and reimbursement. This article discusses to what extent legal requirements dictate the way clinical trials are planned and assessed. Cardiovascular disease is the best example of indications where efficacy and safety are described with the same set of endpoints. It is explained that the assessment of clinical trials must not be restricted to the assessment of primary endpoints. Instead components of a composite endpoint, secondary endpoints, and relevant subgroups of the patient population all require careful inspection. In cases where efficacy and safety are not two sides of the same medal, assessment is either trivial, or extremely difficult, and eventually benefit and risk can be balanced only for individual cases.