临床试验注册数据共享计划的实践和注册和公布数据共享计划之间的一致性:一个横截面研究
Jingyi Zhang1, Barbara E Bierer2,3, Harriette G C Van Spall4,5,6
1Center for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, Guangdong, 510317, China.
BMC medicine
|September 2, 2025
概括
大多数临床试验在注册时没有指定数据共享计划. 超过一半的公布试验显示已注册和实际的数据共享计划之间存在差异,强调需要改善报告和可靠性.
科学领域:
- 临床试验
- 数据共享
- 研究诚信
背景情况:
- 国际医学期刊编辑委员会 (ICMJE) 建议在试验注册和发表期间明确数据共享计划.
- 这些数据共享计划的采用和一致性尚不清楚.
- 本研究评估了试验注册平台的数据共享计划实践及其与已公布计划的一致性.
研究的目的:
- 评估临床试验注册中数据共享计划的普遍性.
- 评估已注册和已公布的数据共享计划之间的一致性.
- 确定与数据共享计划注册和一致性相关的因素.
主要方法:
- 包括在临床试验平台上注册的2021-2023年发表在六个高影响期刊上的临床试验.
- 数据共享计划根据注册中的"计划共享"响应进行评估.
- 在注册计划和公布计划之间分析一致性 (是/是,不/不).
- 单变量分析检查了试验特征与数据共享计划/一致性之间的关联.
主要成果:
- 只有44.6%的注册试验计划共享数据.
- 药物干预增加了登记数据共享计划的几率 (OR=2.71).
- 超过一半 (57. 4%) 的已公布试验显示已注册计划与已公布计划之间存在差异.
- COVID-19 试验数据共享一致率较低 (OR=0.59).
- 在统计分析计划,研究方案,分析代码和个人参与者数据中发现了显著的不一致性.
结论:
- 大多数注册的临床试验缺乏具体的数据共享计划.
- 超过一半的公布试验显示其注册和公布的数据共享意图之间存在矛盾.
- 加强努力至关重要,以提高临床试验数据共享计划的报告准确性和可靠性.
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