PURPOSE: This workshop focuses on recent policy developments, methodological opportunities and challenges of applying patient preference/benefit risk (PP/BR) to regulatory policy and clinical decision-making. It addresses FDA/CDRH’s recent experiences with its draft PP/BR guidance and future plans; FDA/CDER’s perspective; and PCORI’s interests/plans in funding PP/BR methods research. Workshop participants will become familiar with alternative methods for eliciting and summarizing qualitative and quantitative data on patients’ BR tradeoff preferences and critically evaluate how novel stakeholder involvement approaches could influence the evolution of regulatory science and patient-centered CER.  DESCRIPTION: Participants will obtain an overview of recent FDA patient engagement developments and use of qualitative and quantitative preference data. We will review a) how benefit-risk preferences can be quantitatively elicited, b) how regulators have become more patient centered by considering patient perspectives and PP/BR, c) a successful example of PP/BR evidence in a recent regulatory decision, d) perceived gaps in using PP/BR data for future medical product regulatory submissions, and e) how PCORI can support research to fill gaps. We will describe ongoing efforts in PP/BR regulatory science by the Medical Device Innovation Consortium; recent efforts by FDA to elicit patient perspectives and preferences, including advisory­ committee testimony, therapeutic ­area public meetings, FDA patient engagement public­ comment dockets, and draft guidance on including patient­ preference data in regulatory submissions; and how building the evidence base for PP/BR is related to PCORI’s mission, the need for further methodological research on PP/BR, and how such research fits into the portfolio of PCORI’s CER Methods program. Audience participation will include a survey of attendees’ perspectives on patient ­centered benefit-risk analysis; participants will be encouraged to share experience and perspectives. This interactive and informative workshop will be valuable to researchers, clinicians, and industry analysts interested in understanding recent developments and future plans in patient­-centered regulatory benefit-risk assessment.