The CIRS-BRAT Framework comprises a set of principles, processes and tools to help decision-makers select, organize, understand and communicate evidence for pharmaceutical benefit-risk decisions. The Pharmaceutical Research and Manufacturers of America (PhRMA) have addressed the need for improved benefit–risk assessment by supporting the development of a structured, systematic, and transparent approach. The Benefit Risk Action Team (BRAT) was created as part of a 5-year program organized and facilitated by PhRMA; the BRAT was a progressive move that sought to address relevant aspects of benefit and risk assessment. The Benefit Risk Action Team Software Tool (BRAT tool) was developed as a prototype 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. The purpose of the Tool is to enable users to generate value trees, key benefit-risk summary tables and forest plots.

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