The European Medicines Agency (EMA) encourages drug manufacturers to incorporate patient-reported outcomes (PRO) in clinical trials to ensure patients’ perspective and experiences are included in the evaluation of new medicines and in the communication of product value to a range of stakeholders. However, inclusion of PROs in clinical trials does not guarantee patient-reported information on treatment benefit is approved by the EMA for publication in the Summary of Product Characteristics (SmPC) and/or the package leaflets, the key documents used in treatment decision-making. We examined European Public Assessment Reports (EPAR) published by the EMA (https://www.ema.europa.eu/en/medicines) for new non-oncology medicines recommended for approval between 2018 and 2022. The objectives were (1) to review PRO-related statements of product value in the SmPC and package leaflet of non-oncology drugs approved by the EMA between 2018 and 2022 and (2) explore patterns in the way PROs and PRO endpoints are incorporated in clinical trials and how they are evaluated by the EMA. Results from the review will be presented at ISOQOL 2024.
