PURPOSE: The 21st Century Cures Act directs the FDA to identify patient experience data submitted and reviewed as part of an application, and one type of patient experience data is patient preference information. This workshop will explore approaches for demonstrating both patient centeredness and regulatory relevance of patient preference information, through early engagement with patients and regulators. Participants will contribute to a discussion about the value of patient input, how end-user input may refine a patient preference survey, and how patient and regulator perspectives may be synthesized. We will identify opportunities for research to refine and inform good research practices in patient preference survey development. DESCRIPTION: Participants will be presented with a case study on the development of an instrument designed to elicit patient preference information regarding the benefits, risks, and other considerations associated with medical devices to treat Parkinson’s disease. In this study, a review of literature and clinical trials was used to generate a list of potential attributes. Patient input was solicited through discussion groups and a prioritization survey. Clinical and FDA perspectives on using these considerations for regulatory decision-making refined the list. Stephanie Christopher will provide an overview of the motivation, rationale, approach, and results. Margaret Sheehan will give a patient’s perspective on the process, including identification of key success drivers and suggestions for improvement. Anindita Saha will comment on the resulting instrument’s regulatory relevance and pathways for engaging with the FDA during instrument development. Dr. Brett Hauber will relate the work to good research practices and highlight research gaps in this space. Participants will engage in a discussion about research opportunities for patient-centered, fit-for-purpose patient experience data. Their comments will inform the development of a research roadmap.