Development of a Framework for Enhancing the Transparency, Reproducibility and Communication of the Benefit-Risk Balance of Medicines

The current process of benefit-risk assessment of medicines relies primarily on intuitive expert judgment. Frameworks are needed for transparent, rational and defensible decision making that benefits patients, drug developers, and decision makers. The Benefit Risk Action Team framework is a set of processes and tools for selecting, organizing, summarizing, and interpreting data that is relevant to decisions based on benefit-risk assessments. It provides a standardized yet flexible platform for incorporating study outcomes and preference weights as well as for communicating the rationales for decisions.