Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed

Abstract

AbstractObjectiveTo systematically evaluate timely reporting of clinical trial results at medical universities and university hospitals in the Nordic countries.Study Design and SettingIn this cross-sectional study, we included trials (regardless of intervention) registered in the EU Clinical Trials Registry and/orClinicalTrials.gov, completed 2016-2019, and led by a university with medical faculty or university hospital in Denmark, Finland, Iceland, Norway, or Sweden. We identified summary results posted at the trial registries, and conducted systematic manual searches for results publications (e.g., journal articles, preprints). We present proportions with 95% confidence intervals (CI), and medians with interquartile range (IQR). Protocol:https://osf.io/wua3rResultsAmong 2,113 included clinical trials, 1,638 (77.5%, 95%CI 75.9-79.2%) reported any results during our follow-up; 1,092 (51.7%, 95%CI 49.5-53.8%) reported any results within 2 years of the global completion date; and 42 (2%, 95%CI 1.5-2.7%) posted summary results in the registry within 1 year. Median time from global completion date to results reporting was 698 days (IQR 1,123). 856/1,681 (50.9%) ofClinicalTrials.gov-registrations were prospective. Denmark contributed approximately half of all trials. Reporting performance varied widely between institutions.ConclusionMissing and delayed results reporting of academically-led clinical trials is a pervasive problem in the Nordic countries. We relied on trial registry information, which can be incomplete. Institutions, funders, and policy makers need to support trial teams, ensure regulation adherence, and secure trial reporting before results are permanently lost.What is new?-Many Nordic registered clinical trials were reported late or not at all.-Almost one in four trials remained unreported at the end of our search period.-About half of registered trials had reported results two years after completion.-Only 2% of trials posted summary results in the registry one year after completion.-Concerted action is needed to improve reporting of Nordic clinical trials.