[Registration and reporting of results from clinical trials in Nordic countries - there is scope for improvement].

Lakartidningen Pub Date : 2024-06-18
Cathrine Axfors, Gustav Nilsonne
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引用次数: 0

Abstract

Reporting of results from clinical trials is necessary for reliable evidence in clinical decision making, and is mandated as an ethical and regulatory obligation. We have recently followed up reporting of clinical trials in the Nordic countries sponsored by medical universities and university hospitals. Of 2113 studies registered on the EU Clinical Trials Registry (EUCTR) or on clinicaltrials.gov and completed 2016-2019, about half reported results in any form after 24 months and more than one in five did not report results at all. For trials registered on clinicaltrials.gov, about half were prospectively registered. These results are consistent with results from follow-up of registered trials in other contexts and demonstrate that there is scope for improvement in registration and reporting of clinical trials. We urge public sector trial sponsors to enhance their support to trialists in order to ensure that trials are reported in a timely manner.

[北欧国家临床试验结果的登记和报告 - 仍有改进余地]。
报告临床试验结果是临床决策提供可靠证据的必要条件,也是道德和法规规定的义务。最近,我们对北欧国家由医科大学和大学医院赞助的临床试验的报告情况进行了跟踪调查。在欧盟临床试验注册中心(EUCTR)或 clinicaltrials.gov 上注册并在 2016-2019 年完成的 2113 项研究中,约有一半在 24 个月后以任何形式报告了结果,超过五分之一的研究根本没有报告结果。在 clinicaltrials.gov 上注册的试验中,约有一半是前瞻性注册的。这些结果与其他情况下注册试验的跟踪结果一致,表明临床试验的注册和报告工作仍有改进的余地。我们敦促公共部门的试验赞助商加强对试验者的支持,以确保及时报告试验情况。
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
Lakartidningen
Lakartidningen Medicine-Medicine (all)
CiteScore
0.30
自引率
0.00%
发文量
134
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