Rafael Dal-Ré1, Ben Goldacre2, Ignacio Mahillo-Fernández3, Nicholas J DeVito2. 1. Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: rafael.dalre@quironsalud.es. 2. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom. 3. Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain.
Abstract
OBJECTIVE: To describe the trial results reporting behavior of leading European non-commercial sponsors by country and over time. STUDY DESIGN AND SETTING: Cross-sectional analysis describing results reporting rates to the European Clinical Trials Registry among the top sponsors across Europe as of May 2021 and a comparison of reporting trends for a cohort of major sponsors between January 2018 and May 2021. RESULTS: Fifty-nine highly active sponsors from 10 countries and 9 collaborative groups had 1,916 trials due to report, representing 14% of all due trials on the registry (n = 13,709); of these, 1,058 had reported results (55.2%). Sponsors in the UK, Belgium and Germany had the highest compliance at 94%, 69% and 58%; those in Spain, France and the Netherlands, had the lowest, ranging from 4% to 21%. Collaborative groups had a reporting rate of 50%. In the major sponsors cohort (n = 49), those with no reporting to the registry decreased from 27 (55%) in 2018 to 10 (20%) in 2021. Thirteen of these sponsors (27%) reached a 90-100% reporting rate in 2021 compared to 0 in 2018. CONCLUSION: Compliance with EU regulations by non-commercial sponsors is highly variable between countries. Enforcement of EU reporting regulations should be prioritized.
OBJECTIVE: To describe the trial results reporting behavior of leading European non-commercial sponsors by country and over time. STUDY DESIGN AND SETTING: Cross-sectional analysis describing results reporting rates to the European Clinical Trials Registry among the top sponsors across Europe as of May 2021 and a comparison of reporting trends for a cohort of major sponsors between January 2018 and May 2021. RESULTS: Fifty-nine highly active sponsors from 10 countries and 9 collaborative groups had 1,916 trials due to report, representing 14% of all due trials on the registry (n = 13,709); of these, 1,058 had reported results (55.2%). Sponsors in the UK, Belgium and Germany had the highest compliance at 94%, 69% and 58%; those in Spain, France and the Netherlands, had the lowest, ranging from 4% to 21%. Collaborative groups had a reporting rate of 50%. In the major sponsors cohort (n = 49), those with no reporting to the registry decreased from 27 (55%) in 2018 to 10 (20%) in 2021. Thirteen of these sponsors (27%) reached a 90-100% reporting rate in 2021 compared to 0 in 2018. CONCLUSION: Compliance with EU regulations by non-commercial sponsors is highly variable between countries. Enforcement of EU reporting regulations should be prioritized.