In The News
PhRMA Transitions Management of Benefit-Risk Action Team Framework to CIRS
Feb 3, 2012
The BRAT Framework, which was developed over the last six years, is a structured, transparent framework and methodology for benefit-risk assessment. The framework was progressively developed through testing of hypothetical products. Throughout 2011 a voluntary pilot program was conducted among PhRMA member companies to gain practical industry experience with the framework, process and tools and to help facilitate adoption of a more structured approach to benefit-risk assessment by industry and regulators. Experience and feedback collected during the pilot will help support PhRMA’s continued advocacy in this area.
The industry pilot program demonstrated that the principles and tools of the BRAT Framework can be used effectively in a real-world setting. However, full implementation will require stakeholder input from beyond industry, improved incorporation of pilot program results, and further development of benefit-risk assessment principles.
"The agreement with CIRS is a testament to PhRMA’s – and its member companies’ – commitment to the continued development and implementation of a structured benefit-risk framework. We believe that the more-open forum that will be facilitated by CIRS will help to bring these principles into the next phase of utilization," PhRMA Vice President Sascha Haverfield-Gross said.
To that end, CIRS will incorporate the BRAT Framework into its new Unified Methodologies for Benefit-Risk Assessment (UMBRA) Initiative. The goal of UMBRA is to improve benefit-risk assessments during the drug development and regulatory approval process and increase the transparency, predictability and consistency with which benefit-risk assessments are conducted, ultimately enhancing the communication of benefit-risk information between regulators and industry and to patients, healthcare professionals and other stakeholders.
Lawrence Liberti, Executive Director, CIRS, noted that "bringing together elements of two major initiatives will contribute to the shaping of novel approaches to benefit-risk assessment. The grant support provided by PhRMA complements funding from CIRS and will help maintain the momentum that CIRS has established from the relationships and support it has fostered across diverse stakeholders in mature and emerging pharmaceutical markets."
UMBRA will now be expanded to incorporate the BRAT Framework and other CIRS benefit-risk activities, which have focused on the development of an internationally accepted approach for the systematic, routine and standardized documentation of decision making in the benefit-risk assessment of medicines. Among these initiatives, CIRS has developed a framework and related methodology for benefit-risk assessment and initiated a program of work to determine the practical application of the methodology within the review process and this has been piloted by several regulatory agencies. In addition, CIRS intends to coordinate regional regulatory approaches in the Asia Pacific region through the recent initiation of its Southeast Asia Benefit Risk Evaluation (SABRE) program.
About CIRS
CIRS?is a neutral independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. It is governed and operated for the sole support of its members’ activities. CIRS has its own dedicated management and advisory boards, and its funding is derived from membership dues,related activities and grants. For more information, go to www.cirsci.org.
About PhRMA
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.4 billion in 2010 in discovering and developing new medicines. Industry-wide research and investment reached a record $67.4 billion in 2010.?For more information, go to www.phrma.org.
