Abstract

The increasing use of real-world evidence in regulatory, reimbursement, and clinical decision making has highlighted the need for high-quality patient reported outcomes (PROs) collected outside traditional trial environments. Although PROs are well established in controlled clinical trials, their application in prospective real-world studies introduces methodological and operational challenges not fully addressed in existing guidance. As a result, stakeholders face uncertainty about how to generate real-world PRO (RW-PRO) data that are both feasible to collect in routine care and sufficiently robust for decision use.