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

IF 7.3 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Clinical Epidemiology Pub Date : 2025-02-01 DOI:10.1016/j.jclinepi.2025.111710

Gustav Nilsonne , Susanne Wieschowski , Nicholas J. DeVito , Maia Salholz-Hillel , Love Ahnström , Till Bruckner , Katarzyna Klas , Tarik Suljic , Samruddhi Yerunkar , Natasha Olsson , Carolina Cruz , Karolina Strzebonska , Lars Småbrekke , Mateusz T. Wasylewski , Johan Bengtsson , Martin Ringsten , Aminul Schuster , Tomasz Krawczyk , Themistoklis Paraskevas , Eero Raittio , Cathrine Axfors

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引用次数: 0

Abstract

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.

Plain Language Summary

Reporting of results from clinical trials is necessary for evidence-based clinical decision-making. We followed up reporting of clinical trials in the Nordic countries sponsored by medical universities and university hospitals. Of 2112 studies completed 2016–2019 in two major trials registries, about half reported results in any form within 24 months, and more than one in five did not report results at all. These results show that there is a need for improvement in the reporting of Nordic clinical trials.

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在北欧国家，由医科大学和大学医院领导的临床试验的结果报告经常缺失或延迟。

目的：系统评价北欧国家医科大学和大学附属医院临床试验结果的及时报告情况。研究设计和设置：在这项横断面研究中，我们纳入了在欧盟临床试验注册中心和/或ClinicalTrials.gov注册的试验（无论干预措施如何），完成于2016-2019年，由丹麦、芬兰、冰岛、挪威或瑞典的一所拥有医学院或大学医院的大学领导。我们确定了在试验注册中心发布的总结结果，并对结果出版物（例如，期刊文章，预印本）进行了系统的人工搜索。我们用95%置信区间（CI）表示比例，用四分位数间距（IQR）表示中位数。结果：在2112项纳入的临床试验中，1650项（78.1%,95%CI 76.3-79.8%）在我们的随访期间报告了任何结果；1097例（51.9%,95%CI 49.8-54.1%）报告在全球完成日期后2年内有任何结果；48例（2.3%,95%CI 1.7-3.0%）在1年内在注册表中公布了总结结果。从全球完成日期到结果报告的中位时间为690天（IQR 1103）。856/ 1681（50.9%）的临床试验是前瞻性的。丹麦贡献了大约一半的试验。各院校的报告表现差异很大。结论：学术主导的临床试验结果报告缺失和延迟是北欧国家普遍存在的问题。我们依赖于试验注册信息，这可能是不完整的。机构、资助者和决策者需要支持试验团队，确保遵守法规，并在结果永久丢失之前确保试验报告的安全。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Epidemiology 医学-公共卫生、环境卫生与职业卫生

CiteScore

12.00

自引率

6.90%

发文量

320

审稿时长

44 days

期刊介绍： The Journal of Clinical Epidemiology strives to enhance the quality of clinical and patient-oriented healthcare research by advancing and applying innovative methods in conducting, presenting, synthesizing, disseminating, and translating research results into optimal clinical practice. Special emphasis is placed on training new generations of scientists and clinical practice leaders.