% CIRS BRAT Benefit-Risk Tool Past 5 years

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Presentation transcript:

354 43 180 50% CIRS BRAT Benefit-Risk Tool Past 5 years Download Activity 2012 – 2017 50% Top-50 pharmaceutical companies that have downloaded the BRAT Tool Accessed by 354 Overall Accesses Over the Past 5 years 43 Countries from all around the world 180 Organisations Downloads by regulatory agencies (country) Regulators, medicine developers and patients agree that the clear, concise assessment and communication of benefits and harms (risks) is the key to understanding how to make the best use of a new medicine. One assessment approach that has attracted world-wide attention is the CIRS-BRAT Framework. The Framework, comprising the software Tool and the User Guide to the Tool, provide a comprehensive approach to benefit-risk assessment. The Tool enables users to generate value trees, key benefit-risk summary tables and forest plots. In addition, the User Guide to the CIRS-BRAT Framework Process provides a tutorial for benefit-risk analysis and a review of the concepts underpinning this approach. The framework, which was originally developed by the Pharmaceutical Research and Manufacturers of America (PhRMA) Benefit-Risk Action Team (BRAT) was transferred to CIRS in 2012 in order to make the work more broadly available to a diverse, international audience who could benefit from access. Since that time, CIRS made the BRAT benefit-risk assessment Tool available to any party wishing to experiment with this approach through an open website at no cost. The Tool, which also includes a working example using a hypothetical triptan as an assessment case study, is available for download by following the link: CIRS-BRAT Framework Download (http://www.cirs-brat.org/download). CIRS R&D Briefing 66 The CIRS-BRAT Benefit-Risk Assessment Tool: Global use experience 2012-2017 describes the Framework and provides a summary of access since it was made available. From CIRS R&D Briefing 66 The CIRS-BRAT Benefit-Risk Assessment Tool: Global use experience 2012-2017.