A structured approach to benefit-risk assessment is required as the cornerstone of a consistent way to evaluate and communicate observations regarding a medicine’s benefit-risk profile. The Benefit Risk Action Team (BRAT) approached this need by developing a framework and software tool that allows users to generate tabular and graphical displays to assist in the interpretation of benefit and risk findings during the medicine development, submission and post-approval phases. In 2012, the framework and tool were transferred to CIRS in order to make the work initiated by the BRAT more broadly available to a diverse, international audience of users who could benefit from its use.
