Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment.

Measuring the benefits and risks of medicines is the underlying theme whenever the development, review, and regulation of new medicines are discussed. Workshop participants were asked to take the first steps toward defining a framework for benefit-risk (BR) assessment. The framework identifies the essential elements that both regulators and companies should consider throughout the development, review, and postmarketing experience of new medicines in order to apply a consistent approach toward the assessment of BR balance.