Multi-criteria decision analysis applied to a custom-made medicine

摘要

Multi-criteria decision analysis has been supported by the European Medicines Agency to clarify how a decision on the benefit - risk balance for a medicinal product has been reached. Such analysis quantifies benefit and risk and reaches a total score by subtracting risk from benefit. New European pharmaceutical legislation has been proposed to permit timely access to custom-made medicinal products that have licences that are conjoined to those of corresponding master medicinal products. Multi-criteria decision analysis may be used to inform the regulatory position on a master medicinal product but would not be appropriate to decide (prior to first administration) If a named patient would benefit from a custom-made medicine. Multi-criteria decision analysis may be appropriate after a suitable length of exposure to the custom-made medicine.