From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018-2022).

ABSTRACT:

Introduction

Information about a medicine published in the Summary of Product Characteristics (SmPC) and the product's package leaflet by the European Medicines Agency (EMA) is key to communicate its value to prescribers and patients. The aim of this study was to examine the inclusion of statements related to patient-reported outcomes (PROs) in these documents to communicate patients' perspectives and experiences of new nononcology medicines.

Methods

Nononcology therapeutic indications recommended for approval by the EMA between 2018-2022 were identified. The Public Assessment Report(s) (PAR), SmPC, and package leaflet published for each indication were examined. Information about the indication and characteristics relating to how the PROs were assessed in confirmatory studi

SUBMITTER: Sauchelli S 

PROVIDER: S-EPMC12022438 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature