Patient Experience Data
Using patient experience as evidence for decision-making
Key Priorities for Advancing the Understanding and Implementation of Patient Experience Data (PED)
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Promote broad understanding of PED among all stakeholders.
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Recognize that PED can inform decision-making across many areas of healthcare.
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Demonstrate the value of PED for stakeholders in different roles and settings.
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Go beyond discussing methodologies by building case studies and sharing practical lessons learned.
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Ensure that patients remain actively engaged throughout the process to maximize the value of the data—not simply to collect it.
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Enable patients to interpret and understand the meaning of the data.
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Communicate in ways that enable meaningful patient participation (lay communication).
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Actively participate in international discussions on the use of PED in health policy and regulatory decision-making
About PED
Video: Lunchtime Short Seminar
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Patient Experience Data (November 2024)
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Patient Experience Data II (November 2025)
Patient Experience Data (PED) are data that capture patients' experiences, perspectives, needs, and priorities
<Definition by the U.S. Food and Drug Administration (US FDA)
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The symptoms of patients' condition and its natural history
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The impact of the conditions on patients' functioning and quality of life
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Patients' experience with treatments
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Iput on which outcomes are important to patients
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Patient preferences for outcomes and treatments
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The relative importance of any issue as defined by patients
PED includes the following data
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Not only describing group/population characteristics, but individual experiences
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Not only in numbers (quantitative), but in texts (qualitative)
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Not only from medical consultation, but from everyday life
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Not only from clinical studies, but from survey questionnaires, interviews, social listening, etc.
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Not only collected and used by medical professionals, researchers, and companies, but by patients, families, and their advocates
PED Creates non-traditional values for treatment and care
Patient engagement is essential for the use of PED
(Adapted from the Global Patient Experience Data Navigator introductory material)
PE & PED Round Table
1st: October 18, 2025 (Sat) 14:00-18:00
Agenda: Japanese ➡️ English ➡️
Materials and recording: ➡️ *For panelists and participants only
Meeting minutes
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English (original): Yagi N, Hayley C, et al. Proceedings of the First Patient Engagement (PE) and Patient Experience Data (PED) Roundtable in Japan: Advancing the Structured Implementation of PED. Clin Eval 2026;53(3):W1-W16. ➡️
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Japanese translation: Yagi, Chapman, et al. The 1st Roundtable on Patient Participation and Patient Experience Data (PED) in Japan: Towards the Systematic Implementation of PED. Clinical Evaluation 2026;53(3):459-71 (W17-W32). ➡️
PED Training Resource Finder
Roundtable on PE and PED
PE & PED Round Table
This tool allows users to search training materials that were available as of May 2024 (the original materials are in English). The tool was originally developed by the Global Patient Engagement team at Boehringer Ingelheim in Germany. To enable its broad use by diverse stakeholders, Boehringer Ingelheim transferred the tool (Japanese version) to YORIAILab free of charge. The Japanese translation was finalized by YORIAILab.
🟦Click the image on the left to download an interactive version of the file.
Global PED Navigators
The Global Patient Experience Data (PED) Navigator is a tool developed by PFMD to support the planning, collection, and use of Patient Experience Data (PED). YORIAILab contributed to the development of the Japanese translation.
Click the image to open the Japanese version. For more information, please visit the https://pemsuite.org/ped-navigator/ .
Useful Resources
Presentation materials
Websites
Patient Focused Medicines Development. Discover how Patient Experience and Patient Experience Data are closely linked [internet] . https://patientfocusedmedicine.org/patient-experience-data/
References
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Final Concept Paper E22 EWG: General Considerations for Patient Preference Studies. [Internet] May 27, 2024 [cited February 1, 2025]. Available from https://www.ich.org/page/efficacy-guidelines
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Final Concept Paper E22 EWG: General Considerations for Patient Preference Studies . [Internet] 2024 May 27 [cited 2025 Feb 1]. Available at : https://www.ich.org/page/efficacy-guidelines
21st Century Cure Act [Internet], 2016 Dec 13 [cited 2025 Feb 1] (United States of America).
Available at https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
US Department of Health and Human Services Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders . [Internet] 2020 Jun [cited 2025 Feb 1]. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-collecting-comprehensive-and-representative-input
US Department of Health and Human Services Food and Drug Administration. Patient-Focused Drug Development: Methods to Identify What Is Important to Patients : Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders . [Internet] 2022 Feb [cited 2025 Feb 1]. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-collecting-comprehensive-and-representative-input