All Times EDT
Keywords: Scientific Working Group, Collaboration, Benefit Risk, R-Shiny
In recent years, there has been continual growing interest in structured approaches for the benefit-risk assessment of pharmaceutical products. Recent developments include the FDA draft guidance for benefit-risk and ongoing initiatives including CIOMS XII, IMI-PREFER, and the Benefit-Risk Special Interest Group of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI). The Benefit Risk Assessment Planning (BRAP) and Benefit Risk Assessment Tool Suite (BRATS) teams are part of the Interdisciplinary Safety Evaluation Workstream of the ASA Biopharm Safety Working Group. The teams are multidisciplinary, consisting of physicians, statisticians, and other scientists. The aims of the BRAP and BRATS teams are to provide guidance for benefit-risk planning and tools to assist the assessment of benefit-risk. The BRAP is developing a benefit-risk planning template that incorporates global regulatory expectations and existing safety assessment processes in drug development programs. The BRAP template will provide a modularized framework that accounts for the stage of the product lifecycle and includes key features to assist in decision-making and facilitate interactions between regulatory agencies and industry sponsors. The BRATS team is creating an interactive tool suite in alignment with the BRAP template. The initial suite will include interactive benefit-risk value trees, forest plots and effects tables and will further expand to other tools as they are developed. The tool suite will use R-Shiny and will be freely available to stakeholders to assist in benefit risk assessment.
We will use this roundtable as a forum to discuss recent activities of these two teams: current status, lessons learned, and future goals. We are also seeking feedback on the goals and approaches, and gauging interest for additional collaborators.