A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020.

ABSTRACT:

Introduction

Cancer and corresponding available treatments are associated with substantial symptoms and functional limitations. In this context, collection of patient-reported outcomes (PRO) in clinical trials gained special interest and is recommended by regulatory authorities. Within clinical trials framework, PRO may provide evidence to support medicines approval, labeling and marketing claims. This study aims to analyze the existing evidence based on PRO as part of new oncology indications receiving positive opinions issued by the European Medicines Agency (EMA) between 2017 and 2020 and to identify PRO related label claims granted.

Methodology

Oncology medicinal products and indications approved by the European Commission following a positive opinion from the EMA betwee

SUBMITTER: Teixeira MM 

PROVIDER: S-EPMC9411861 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature