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.
In 2012, the work of the BRAT was transferred to CIRS- the Centre for Innovation in Regulatory Science (www.cirsci.org) and the tool has since been available through this web site at no cost to interested parties. In collaboration with Dr Bennett Levitan (J&J) and colleagues, an updated version of the tool which also includes a working example of the CIRS-BRAT software using a hypothetical triptan as an assessment case study has been developed and is available for download below.
The Tool and its User Guide provide a comprehensive approach to benefit-risk assessment. In addition, the User Guide to the CIRS-BRAT Framework Process provides a tutorial of benefit-risk analysis and a review of the concepts underpinning this approach.
In order to continue the work initiated by the BRAT, CIRS is pleased to make the CIRS-BRAT Tool available to any party wishing to experiment with this approach. The CIRS-BRAT Tool is available free of charge and subject to the provisions of the Terms and Conditions available on this site.
The following items form the CIRS-BRAT package which is available as a single zipped download:
- CIRS-BRAT Software beta v3.02
- CIRS-BRAT Software beta v3.02 with triptan example data
- The User Guide to the Tool
- The User Guide to the CIRS-BRAT Framework Process
For any queries please send an e-mail to: firstname.lastname@example.org