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Results reporting for clinical trials led by medical universities and university hospitals in the nordic countries was often missing or delayed
Karolinska Institutet, Sweden;Stockholm University, Sweden;Charite Univ Med Berlin, Germany.ORCID iD: 0000-0001-5273-0150
Charite Univ Med Berlin, Germany.
Univ Oxford, UK.
Charite Univ Med Berlin, Germany.ORCID iD: 0000-0003-1934-9504
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2025 (English)In: Journal of Clinical Epidemiology, ISSN 0895-4356, E-ISSN 1878-5921, Vol. 181, article id 111710Article in journal (Refereed) Published
Abstract [en]

Objectives: To systematically evaluate timely reporting of clinical trial results at medical universities and university hospitals in the Nordic countries. Study Design and Setting: In this cross-sectional study, we included trials (regardless of intervention) registered in the European Union (EU) Clinical Trials Registry and/or ClinicalTrials.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 (eg, journal articles, preprints). We present proportions with 95% confidence intervals (CI) and medians with interquartile range (IQR). Protocol: https://osf.io/wua3r. Results: Among 2112 included clinical trials, 1650 (78.1%, 95% CI 76.3%-79.8%) reported any results during our follow-up; 1097 (51.9%, 95% CI 49.8%-54.1%) reported any results within 2 years of the global completion date; and 48 (2.3%, 95% CI 1.7%-3.0%) posted summary results in the registry within 1 year. The median time from global completion date to results reporting was 690 days (IQR 1103). 856/1681 (50.9%) of ClinicalTrials.gov registrations were prospective. Denmark contributed approximately half of all trials. Reporting performance varied widely between institutions. Conclusion: Missing and delayed results reporting of academically led clinical trials are a pervasive problem in the Nordic countries. We relied on trial registry information, which can be incomplete. Institutions, funders, and policymakers need to support trial teams, ensure regulation adherence, and secure trial reporting before results are permanently lost. (c) 2025 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Place, publisher, year, edition, pages
Elsevier, 2025. Vol. 181, article id 111710
Keywords [en]
Trial registration, Publication bias, Metascience, Clinical trials, Evidence-based medicine, Missing results
National Category
Other Medical Sciences not elsewhere specified
Research subject
Health and Caring Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-137436DOI: 10.1016/j.jclinepi.2025.111710ISI: 001444491800001PubMedID: 39900256Scopus ID: 2-s2.0-85219243130OAI: oai:DiVA.org:lnu-137436DiVA, id: diva2:1948535
Available from: 2025-03-31 Created: 2025-03-31 Last updated: 2025-04-16Bibliographically approved

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Willén, Rebecca M.

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Nilsonne, GustavSalholz-Hillel, MaiaKlas, KatarzynaYerunkar, SamruddhiOlsson, NatashaRingsten, MartinRaittio, EeroBruschettini, MatteoWillén, Rebecca M.
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