相关实验视频
Updated: Jun 8, 2026

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Establishment of a Clinic-based Biorepository
Published on: May 29, 2017
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在提交给BMJ的临床试验中注册非前性试验的分析:观察性研究
David Blanco1, Elizabeth Loder2,3, Sophie Cook3
1Department of Physiotherapy, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Barcelona, Spain dblanco@uic.es.
概括
许多未在国际医学期刊编辑委员会 (ICMJE) 进行前性注册的临床试验后来在具有影响力的期刊上发表. 作者经常未能披露注册缺陷,尽管声称遵守ICMJE指南.
科学领域:
- 临床试验注册和出版伦理学
- 医学期刊的政策和合规性
背景情况:
- 临床试验的未来注册对于透明度和科学完整性至关重要.
- 国际医学期刊编辑委员会 (ICMJE) 建议在未来进行注册.
研究的目的:
- 确定与向BMJ提交的临床试验的非前性注册相关的因素.
- 检查这些试验的注册缺陷,披露做法和出版状态.
- 评估作者关于潜在注册的说法.
主要方法:
- 观察性研究比较了239个未被预先注册的试验和239个预先注册的试验提交给BMJ (2019-2023年).
- 分析包括注册状态,缺陷,注册延迟和随后的出版细节.
- 评估了作者关于未来注册和期刊遵守ICMJE建议的说法.
主要成果:
- 与减少非前景注册相关的因素包括更大的样本大小,来自大洋洲的作者,更多的作者,提到CONSORT,最近的提交和资金.
- 来自亚洲的作者有更高的无前景注册的几率.
- 在未被前性地注册的试验中,83%被追溯地注册 (中位数延迟193天),13%未被注册. 大多数后来发表在影响因素期刊上,经常声称ICMJE遵守而不披露注册问题. 83%的作者错误地声称可能注册.
结论:
- 由于没有前景注册而被英国医学杂志拒绝的试验经常在其他地方发表在具有影响力的期刊上.
- 这些期刊经常声称遵守ICMJE,但作者经常未能披露注册缺陷.
- 这突显了临床试验注册政策的遵守和执行方面的差距.
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