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Updated: Jun 24, 2025

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临床试验中数据共享声明的日志要求:一个横截面研究
Jingyi Zhang1, Yingxin Liu1, Lehana Thabane2
1Center for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, China.
Journal of clinical epidemiology
|June 5, 2024
概括
大多数生物医学期刊现在要求临床试验的数据共享声明,提高透明度. 然而,超过27%的人仍然没有这样做,这表明需要更广泛地采用这些数据透明度实践.
科学领域:
- 临床试验报告和数据透明度
- 生物医学期刊政策和数据共享
背景情况:
- 数据共享声明对于临床试验透明度至关重要.
- 国际医学期刊编辑委员会 (ICMJE) 要求对临床试验进行数据共享声明.
研究的目的:
- 评估对生物医学期刊中个人参与者数据共享声明的要求.
- 探索期刊特征与数据共享声明要求的实施之间的关联.
主要方法:
- 通过期刊引用报告 (2019-2022) 索引的3229个生物医学期刊的横截面研究.
- 分析有关数据共享声明的期刊政策.
- 多变量后勤回归用于识别与数据共享声明要求相关的因素.
主要成果:
- 72.6%的期刊 (2345/3229) 要求提供数据共享声明.
- 在英国出版的期刊和那些支持统一报告试验标准 (CONSORT) 的期刊显示,要求陈述的几率更高.
- 开放获取,非英语,临床医学和ICMJE上市的期刊要求数据共享声明的几率较低.
结论:
- 发表临床试验的大量生物医学期刊 (超过27%) 不要求数据共享声明.
- 这一差距突出了改善临床研究数据透明度的机会,尽管现有建议.
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