Balancing modern medical benefits and risks

Abstract

The changing landscape of medical benefits and risks creates new challenges for all stakeholders in health care. We offer examples of different medical interventions to help illustrate the complexity and diversity of considerations that define the trade-offs between benefits and risks for each patient. As more information becomes available at all stages of a product's life cycle, the Food and Drug Administration (FDA) needs to play a central role as an authoritative voice in communicating drugs' benefits and risks and must have the resources to perform the functions necessary to keep pace with this accelerating rate of change.