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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

Nilsonne, Gustav ; Wieschowski, Susanne ; DeVito, Nicholas J ; Salholz-Hillel, Maia ; Ahnström, Love ; Bruckner, Till ; Klas, Katarzyna ; Suljic, Tarik ; Yerunkar, Samruddhi and Olsson, Natasha , et al. (2025) In Journal of Clinical Epidemiology 181.
Abstract

OBJECTIVE: 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 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 (e.g., journal articles, preprints). We present proportions with 95% confidence intervals (CI), and medians with interquartile range... (More)

OBJECTIVE: 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 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 (e.g., journal articles, preprints). We present proportions with 95% confidence intervals (CI), and medians with interquartile range (IQR).

PROTOCOL: https://osf.io/wua3r RESULTS: Among 2,112 included clinical trials, 1,650 (78.1%, 95%CI 76.3-79.8%) reported any results during our follow-up; 1,097 (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. Median time from global completion date to results reporting was 690 days (IQR 1,103). 856/1,681 (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 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.

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organization
publishing date
type
Contribution to journal
publication status
epub
subject
in
Journal of Clinical Epidemiology
volume
181
article number
111710
publisher
Elsevier
external identifiers
  • pmid:39900256
  • scopus:85219243130
ISSN
0895-4356
DOI
10.1016/j.jclinepi.2025.111710
language
English
LU publication?
yes
additional info
Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.
id
b9c21474-4673-4605-929b-ed8bf9a64760
date added to LUP
2025-02-27 14:10:13
date last changed
2025-07-07 09:43:56
@article{b9c21474-4673-4605-929b-ed8bf9a64760,
  abstract     = {{<p>OBJECTIVE: To systematically evaluate timely reporting of clinical trial results at medical universities and university hospitals in the Nordic countries.</p><p>STUDY DESIGN AND SETTING: In this cross-sectional study, we included trials (regardless of intervention) registered in the 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 (e.g., journal articles, preprints). We present proportions with 95% confidence intervals (CI), and medians with interquartile range (IQR).</p><p>PROTOCOL: https://osf.io/wua3r RESULTS: Among 2,112 included clinical trials, 1,650 (78.1%, 95%CI 76.3-79.8%) reported any results during our follow-up; 1,097 (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. Median time from global completion date to results reporting was 690 days (IQR 1,103). 856/1,681 (50.9%) of ClinicalTrials.gov-registrations were prospective. Denmark contributed approximately half of all trials. Reporting performance varied widely between institutions.</p><p>CONCLUSION: Missing 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.</p>}},
  author       = {{Nilsonne, Gustav and Wieschowski, Susanne and DeVito, Nicholas J and Salholz-Hillel, Maia and Ahnström, Love and Bruckner, Till and Klas, Katarzyna and Suljic, Tarik and Yerunkar, Samruddhi and Olsson, Natasha and Cruz, Carolina and Strzebonska, Karolina and Småbrekke, Lars and Wasylewski, Mateusz T and Bengtsson, Johan and Ringsten, Martin and Schuster, Aminul and Krawczyk, Tomasz and Paraskevas, Themistoklis and Raittio, Eero and Herczeg, Luca and Hesselberg, Jan-Ole and Karlsson, Sofia and Borana, Ronak and Bruschettini, Matteo and Mulinari, Shai and Lizárraga, Karely and Siebert, Maximilian and Hildebrand, Nicole and Ramakrishnan, Shreya and Janiaud, Perrine and Zavalis, Emmanuel and Franzen, Delwen and Boesen, Kim and Hemkens, Lars G and Naudet, Florian and Possmark, Sofie and Willén, Rebecca M and Ioannidis, John P and Strech, Daniel and Axfors, Cathrine}},
  issn         = {{0895-4356}},
  language     = {{eng}},
  month        = {{02}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Clinical Epidemiology}},
  title        = {{Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed}},
  url          = {{http://dx.doi.org/10.1016/j.jclinepi.2025.111710}},
  doi          = {{10.1016/j.jclinepi.2025.111710}},
  volume       = {{181}},
  year         = {{2025}},
}