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德国大学医学中心进行的临床试验的结果发布延迟且不完整。

Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete.

机构信息

Institute for Ethics, History, and Philosophy of Medicine, Hannover Medical School, Hannover, Germany.

QUEST Center for Transforming Biomedical Research, Berlin Institute of Health, Berlin, Germany.

出版信息

J Clin Epidemiol. 2019 Nov;115:37-45. doi: 10.1016/j.jclinepi.2019.06.002. Epub 2019 Jun 10.

Abstract

OBJECTIVES

Timely and comprehensive reporting of clinical trial results builds the backbone of evidence-based medicine and responsible research. The proportion of timely disseminated trial results can inform alternative national and international benchmarking of university medical centers (UMCs).

STUDY DESIGN AND SETTING

For all German UMCs, we tracked all registered trials completed between 2009 and 2013. The results and an interactive website benchmark German UMCs regarding their performance in result dissemination.

RESULTS

We identified and tracked 2,132 clinical trials. For 1,509 trials, one of the German UMCs took the academic lead. Of these 1,509 "lead trials," 39% published their results (mostly via journal publications) in a timely manner (<24 months after completion). More than 6 years after study completion, 26% of all eligible lead trials still had not disseminated results.

CONCLUSION

Despite substantial attention from many stakeholders to the topic, there is still a strong delay or even absence of result dissemination for many trials. German UMCs have several opportunities to improve this situation. Further research should evaluate whether and how a transparent benchmarking of UMC performance in result dissemination helps to increase value and reduce waste in medical research.

摘要

目的

及时全面地报告临床试验结果是循证医学和负责任研究的基础。及时传播试验结果的比例可以为大学医学中心(UMC)提供替代的国家和国际基准。

研究设计和设置

对于所有德国 UMC,我们跟踪了 2009 年至 2013 年间完成的所有注册试验。结果和一个互动网站为德国 UMC 在结果传播方面的表现提供了基准。

结果

我们确定并跟踪了 2132 项临床试验。在 1509 项试验中,一家德国 UMC 担任学术牵头机构。在这 1509 项“牵头试验”中,39%及时(完成后<24 个月)公布了结果(主要通过期刊发表)。在研究完成 6 年多后,仍有 26%的合格牵头试验尚未传播结果。

结论

尽管许多利益相关者对该主题给予了大量关注,但许多试验仍存在明显的延迟甚至缺乏结果传播。德国 UMC 有几个机会可以改善这种情况。进一步的研究应该评估在结果传播方面对 UMC 绩效进行透明基准测试是否有助于提高医学研究的价值并减少浪费。

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