Session (CTI)

As real-world evidence (RWE) continues to play an increasingly central role in healthcare decision making, there is growing recognition that patient experience data (PED) should be more systematically and meaningfully integrated to ensure RWD and evidence generation reflect what matters most to patients. PED cannot be fully understood or responsibly applied without intentional and sustained patient engagement (PE) across the research lifecycle. Without PE, PED risks being incomplete, misinterpreted, or disconnected from lived experience. Despite the overall positive trend in the increasing use of both terms (PE and PED) across regulatory and health technology assessment (HTA) contexts, practical challenges remain in aligning PED with RWE methods, standards, and use cases. Many RWD studies continue to prioritize clinical and administrative data while underutilizing PED, limiting the relevance and impact of RWE for patients. Building on recent methodological advances, regulatory developments from EMA and FDA emphasizing the importance of incorporating PED, and insights from the ISPOR Global Patient Representatives Meeting, this session will highlight how PED can strengthen the relevance, credibility, and usability of RWE for healthcare decision making. Panelists will discuss current gaps and challenges incorporating PED into RWE, emerging frameworks for meaningful patient involvement, and case examples and practical approaches for how PED has informed RWE. By centering patient engagement as foundational to PED, this forum aims to promote more transparent, patient-centered, and globally applicable RWE. An interactive discussion with the audience will help inform the development of additional guidance, frameworks, and tools to advance shared understanding of more patient-centered RWE. This Forum will be presented on behalf of the ISPOR Patient Council.