- 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://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.
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