临床试验数据共享声明:心脏病学期刊的横截面调查
Yingxin Liu1, Jingyi Zhang1, Xinru Peng2
1Center for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, China.
BMJ open
|July 23, 2025
概括
大多数心脏病学期刊现在要求临床试验的数据共享声明. 然而,大约有四分之一的人没有,许多期刊在要求陈述和其出版之间显示出不一致.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 科学出版科学出版
背景情况:
- 国际医学期刊编辑委员会要求在试验出版物中提供数据共享声明.
- 心脏病学期刊在提交文件中要求这些陈述的程度尚不清楚.
研究的目的:
- 调查心脏病学期刊关于他们对临床试验提交的数据共享声明的要求.
- 评估期刊请求的数据共享声明与其实际在试验报告中发表的数据共享声明之间的一致性.
主要方法:
- 对2019年1月至2022年12月期间发表临床试验的心脏和心血管系统期刊的调查.
- 多变量后勤回归分析,以确定与请求数据共享声明相关的因素.
- 探索日志请求和发表声明之间的一致性.
主要成果:
- 在126个期刊中,有96个 (76.2%) 要求数据共享声明.
- 来自爱思唯尔的期刊和那些支持综合报告标准的期刊显示,要求陈述的几率更高.
- 在要求发表陈述的期刊中,30.8%的期刊未能在试验报告中发表陈述.
结论:
- 很大一部分心脏病学期刊 (约25%) 不要求临床试验提交的数据共享声明.
- 心脏病学期刊对数据共享声明的声明要求和它们在发表的试验报告中的实施之间存在显著的差异.
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