Disparities in access to oncology clinical trials in Europe in the period 2009-2019

peer reviewedBackground: Clinical trials are essential for advancing cancer treatment. Yet, there is limited data on their distribution and access in Europe. To ascertain the extent of potential inequalities in access to clinical trials in Europe, we compared their distribution among European countries. Methods: The Clinicaltrials.gov database was searched for interventional clinical trials in adults with neoplasms. Available data from phase I-III trials between 06/2009 to 06/2019 in Europe were retrieved. We considered the number of clinical trials registered in each country and one “trial-entry” was defined as one trial/country. Results: In total, 18454 trial-entries were identified, of which 12% were phase I, 10% phase I/II, 32% phase II, 2% phase II/III and 44% phase III; 74% were industry-sponsored, 15% were academic and 11% were an academic/industry partnership. The number of trials per country varied from 2.48 in Central/Eastern Europe to 5.33/100 000 inhabitants in Northern Europe. The proportion of phase I-II trials was higher in the Southern and Western regions (13-15%) compared to Central/Eastern and Northern regions (4-9%). The number of trial-entries/100 000 inhabitants/country ranged from 0.14 (Albania) to 10.7 (Belgium). Between 2010 and 2018, the total number of trials per country in Europe increased by 33%. The increase in early-phase trials was larger (phase I-II, 61%) than in late-phase trials (phase II-III, 7%). Portugal, Ireland, Finland, Greece and Norway registered the largest percentage increase in early-phase trials, while Ireland, Spain, Norway, Italy and Belgium led the largest percentage increase in late-phase trials. Five countries dominated in terms of an increase in the absolute number of total trial-entries in both early- and late-phase trials: Spain (90/40), France (45/16), UK (45/13), Italy (38/19) and Belgium (35/12). During this period there was no significant variation in the distribution of industry and academic sponsored trials but an increase in industry/academic partnerships was observed (= 8%). Conclusions: The number of clinical trials varies greatly among European regions resulting in potential asymmetries in patients’ access to clinical trials. The disparities in access to oncology trials need to be addressed by all the stakeholders