ISPOR Good Practices Task Force on Patient-Reported Outcomes (PROs) in Prospective Real-World Studies: Preliminary Recommendations

Global regulators, health technology assessors, and policy makers have indicated that patient reported outcome (PRO) data can provide valuable information on the effectiveness, safety and tolerability of new health technologies from the patient perspective. Existing PRO guidance focuses on the use of PRO measures in a controlled trial setting. However, little guidance exists regarding the use of PROs in real world (RW) studies. An ISPOR task force is in the process of developing a good practices report for use of these measures in RW Studies. This session will present the task force’s findings thus far focused on realising the value of PROs in RW studies and the preliminary recommendations regarding study population, data quality, RW-PRO implementation, treating patients as partners, data analysis, technology and validity of PRO measure in RW context. Speakers will present case examples and consider the methodological and logistical requirements of data to be acceptable to different stakeholder groups - discussed from research, regulatory, and industry standpoints, respectively. ISPOR community feedback is an essential step in the optimisation of an ISPOR expert consensus-developed good practices reports. Feedback will be sought on the preliminary recommendations. Audience examples and comments on the use of real-world patient reported outcomes (RW-PROs) data in regulatory and payer submissions are encouraged. This session is designed for researchers, payers, regulators, technology assessors, and industry professionals, offering a unique opportunity to explore the intersection of PROs, real-world evidence, and patient-centered research.