一项关于英国研究人员关于他们对临床试验数据集去识别,匿名化,释放方法和重新识别风险估计的经验的观点的调查
Aryelly Rodriguez1, Steff C Lewis1, Sandra Eldridge2
1Edinburgh Clinical Trials Unit, Usher Institute, The University of Edinburgh, Edinburgh, UK.
Clinical trials (London, England)
|February 10, 2025
概括
由于缺乏标准化指导,研究人员面临分享匿名临床试验数据的挑战. 资源,培训和重新识别风险估计发展不足的差距阻碍了数据共享的努力.
科学领域:
- 临床研究数据管理
- 医疗保健中的数据隐私和安全性
背景情况:
- 越来越多的需求共享匿名临床试验数据集用于二级研究.
- 缺乏对匿名化和准备共享临床试验数据的标准化建议.
- 随着匿名数据集的日益普及,需要明确的数据共享协议.
研究的目的:
- 探索英国研究人员对临床试验数据集的非识别,匿名化和发布方法的看法和经验.
- 调查当前的实践和挑战,准备临床试验数据共享.
- 评估重新识别风险估计技术的认识和应用.
主要方法:
- 采用了在线探索性横截面描述性调查.
- 该调查包括开放式和封闭式问题,以收集全面的数据.
- 数据收集时间为2022年6月至2022年10月.
主要成果:
- 92%的参与者使用了内部或公布的指导方针去识别/匿名.
- 控制访问,涉及非识别,匿名化和数据持有人要求,是最常见的发布方法 (47%).
- 只有29%的人知道重新识别风险估计,但没有人使用这些方法;经验在很大程度上是负面的,因为缺乏资源,指导和培训.
结论:
- 大多数研究人员都使用了记录下来的去识别和匿名化过程.
- 在临床试验数据共享的指导,资源和培训方面仍然存在重大差距.
- 重新识别风险估计仍然是临床试验数据匿名化实践中欠发达的领域.
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