Basic aspects of risk-benefit analysis.

Abstract

The benefit of a medicinal product is to be determined separately for each of its indications. It may be seen as the product from the individual therapeutic efficacy and the responder rate. A half-quantitative representation would be a rectangle with these two sides. According to their reliability and importance, the benefit data can be arranged in a "hierarchy of evidence." If the benefit rectangle is graphically multiplied by the dimension of evidence, a cuboid is obtained for the evidence-weighted benefit. The benefit in a given indication is contrasted with the risks resulting from the totality of all adverse drug reactions (ADRs). Like the drug benefit, each ADR-related risk can be represented as the product, or rectangle, from ADR seriousness in an individual case and ADR frequency. If the risk is multiplied by the respective data evidence, a cuboid is obtained for the evidence-weighted risk. The benefit-risk relation is most favorable for that medicinal product whose cuboid for the evidence-weighted benefit outbalances the sum of all cuboids for the evidence-weighted risks by the greatest margin.