Weighing benefit–risk of medicines: concepts and approaches

Formal methods for decision-making based on benefit–risk analysis have existed for many years in various settings, but have only recently being explored in Medicine for use by various stakeholders including patients, physicians, regulators and pharmaceutical industry. We review the rationale for using these formal approaches; describe the basic concepts required; outline some competing approaches that have been proposed, illustrating them with examples, refer more briefly to other approaches and describe current initiatives in this domain.