A Review of Patient-Reported Outcome Data for Palliative Cancer Drugs Approved In the European Union

Background: Results from patient reported outcome (PRO) are often undermined due to methodological issues thus limiting patient centeredness in clinical research for development of palliative cancer medicines. Objective: The aim of this study was to identify the rate and type of PRO data included in the Summary of Product Characteristics (SmPC) for cancer palliative drugs approved in the European Union (EU) by December 21st 2017. Results: From 115 approved cancer drugs, 6 or only 5.2% included PRO data in their SmPC about palliative cancer care, constituted by 4 international non-proprietary names (INNs) within 3 indications. Not all of them were used as a primary endpoint in the pivotal clinical trials. Conclusion: The rate of PRO data included in the SmPC’s of palliative cancer drugs approved in EU is very low and therefore all stakeholders should be encouraged to wider use of PRO tools in clinical research and development of palliative cancer medicines. Keywords: Patient-reported outcomes; Cancer; Palliative drugs; Summary of product characteristic