作者
Gustav Nilsonne, Susanne Wieschowski, Nicholas J DeVito, Maia Salholz-Hillel, Till Bruckner, Katarzyna Klas, Tarik Suljic, Samruddhi Yerunkar, Natasha Olsson, Carolina Cruz, Karolina Strzebonska, Lars Smabrekke, Mateusz T Wasylewski, Johan Bengtsson, Martin Ringsten, Aminul Schuster, Tomasz Krawczyk, Themistoklis Paraskevas, Love Ahnstrom, Eero Raittio, Luca Herczeg, Jan-Ole Hesselberg, Sofia Karlsson, Ronak Borana, Matteo Bruschettini, Shai Mulinari, Karely Lizarraga, Maximilian Siebert, Nicole Hildebrand, Shreya Ramakrishnan, Perrine Janiaud, Emmanuel Zavalis, Delwen L Franzen, Kim Boesen, Lars G Hemkens, Florian Naudet, Sofie Possmark, Rebecca M Willen, John PA Ioannidis, Daniel Strech, Cathrine Axfors
发表日期
2024
期刊
MedRxiv
页码范围
2024.02. 04.24301363
出版商
Cold Spring Harbor Laboratory Press
简介
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 2,113 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%) 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 …
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