Session (CTI)

PURPOSE: Real-world evidence (RWE) and patient-centred research, as captured through patient-reported outcomes (PROs), are critical to the ISPOR community. Prospective real-world (RW) studies offer an opportunity to collect PRO data, providing valuable insights into effectiveness, safety, and tolerability from the patient perspective. Global regulators, health technology assessors, and policymakers recognize the importance of PROs in RWE; however, there is limited guidance on their optimal use in RW studies. An ISPOR Task Force is developing a good practices report to address this gap. A key component of this effort is gathering multi-stakeholder perspectives on the value, use, and acceptability of RW-PRO data across different geographies. This session aims to consolidate feedback from ISPOR members on the draft report and explore how RW-PRO data can meet stakeholder needs. Additionally, we seek recommendations on ensuring the report’s relevance across regions and identifying next steps for further research and guidance.

DESCRIPTION: This session will present the task force’s findings on maximizing the value of PROs in RW studies. Key emerging recommendations include: working with patients as partners, defining appropriate study population, ensuring PRO instrument suitability in RW settings, maintaining data quality, implementing PROs effectively, analyzing PRO data, leveraging technology, and engaging with regulators and payers. Audience input will be sought on these good practices, helping refine the recommendations for RW-PRO data collection and use. The session will conclude by identifying evidence gaps and areas for further research to enhance the integration of PROs in RWE. Designed for researchers, payers, regulators, technology assessors, and industry professionals, this session provides a unique opportunity to discuss the evolving landscape of PROs in RW studies and their role in patient-centred evidence generation.