Presentation (CTI)

OBJECTIVES: Patient-centered research (PCR) is a key driver to bring patients’ voices and insights into HEOR and RWE. Relevant approaches include qualitative and quantitative methods including interviews, patient surveys, patient-preference studies, vignette studies, and patient advisory activities. However, Western approach may require substantial adaptation before implementation in Japan due to its regulatory, ethical, and institutional requirements. This study developed a practical framework for Japanese PCR implementation, addressing multifaced regulatory, ethical, and operational consideration.
METHODS: We synthesized information from Japanese regulatory and ethical documents, supplemented by international literature on PCR methodologies and our experience. The proposed practical framework includes eight domains: 1) study positioning, 2) regulatory/ethical classification, 3) sponsor/COI transparency, 4) site engagement/approval, 5) recruitment, 6) instrument adaptation, 7) data governance, and 8) evidence dissemination.
RESULTS: Based on our proposed practical framework, critical Japan-specific considerations include: (1) clarifying study positioning (e.g., academic vs. industry-sponsored research, research purpose) because this dictates ethical pathways and institutional acceptance; (2) navigating limited direct patient access through early multi-stakeholder engagement -- including principal investigators, and clinical, administrative, and legal departments -- given Japan’s ethical and institutional-level practices; and (3) addressing institutional caution toward pharmaceutical sponsors through transparent disclosure of study purpose, data flows, and safeguards against promotion. Additional challenges involve managing health data as sensitive personal information, institution-level variability in contracting, and the need for deep cultural/conceptual adaptation of interview guides and PRO/COA instruments. While PMDA indicates growing interest in patient voices, practical pathways for generating and using patient-centered evidence in Japan continue to evolve.
CONCLUSIONS: Japanese PCR implementation requires more than simple translation. This structured Japan-specific framework may help global and local researchers to design scientifically robust and operationally feasible research that align with Japan’s regulatory/ethical and healthcare environment.