The CIRS-BRAT Framework

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 ( 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:


The CIRS-BRAT FrameworkDownloadTerms and Conditions