European Atlas on Clinical Trials in Cancer and Hematology (EuroACT): Patient Access Disparities and Underuse of Patient Reported Outcome Measures

OBJECTIVES: The primary objective of EuroACT is to comprehensively analyze the landscape of clinical trials in the European region, encompassing 27 disease areas in oncology and hematology. This analysis focuses on three main aspects: geographical distribution of clinical trial sites across Europe; extent to which patient-reported outcomes (PROs) are collected in clinical trials; and publication rates of PRO data gathered during trials.

METHODS: Predefined term searches were conducted on EU EudraCT and the US ClinicalTrials datasets to compile a fit-for-purpose database on interventional and observational trials. Only trials completed after 01.01.2017 were included, which investigated 27 disease areas registered in at least one European country (as defined by WHO) and not in Phase 1 studies. PROs were identified based on preliminary literature search and publication data derived from PubMed.

RESULTS: Analysis of 5,171 completed trials revealed substantial geographical disparities. Western Europe hosted the highest proportion of trials (73,4%), followed by Central and Eastern Europe (57%), Southern Europe (56,5%) and Northern Europe (31,4%). Only 19% of trials incorporated PRO measures. The most frequently used PRO instruments were the EORTC-QLQ-C30, EQ-5D and SF-36. Disease areas where PROs were most frequently measured, included chronic lymphoid leukemia, lymphomas, and neuroendocrine cancers. Only 17% of trials had associated publications on PubMed, out of which only a few trials included PRO data.

CONCLUSIONS: Significant geographical disparities in access to oncology and hematology clinical trials exist and are actionable barriers to innovative treatments across different European regions. Publication of trial results are inconsistent and can contribute to patient mistrust in the clinical trial landscape. Only a subset of published trials incorporated PRO measures, and their data are infrequently published. Collectively, this analysis highlights a critical gap in capturing the patient voice, which is indispensable for improving treatment strategies.