Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products

This session will examine real-world implementation of patient engagement in benefit-risk assessment and will begin a deeper exploration with the group of methodological and operational challenges and how these may be addressed to assure the capture and incorporation of patient input. Special focus will be placed on the impact and accommodation of crosscutting factors such as what types of medical treatment/benefit-risk situations lend themselves to patient preference assessment, when in development should patient preferences be assessed, whose input should be elicited (e.g., group vs. individual input, experienced patients vs. the community at large), and how can heterogeneity in patient populations and their views be handled. Practical challenges for researchers, including managing diverse views within companies and across disciplines will also be discussed. There will be a 10 minute Q&A with each speaker after their presentation.