在线随机试验中识别和控制欺诈参与的经验教训
Robert Siebers1, Kara M Magane1, Hattie Slayton1
1School of Public Health, Boston University, Boston, MA, United States.
Journal of medical Internet research
|October 29, 2025
概括
在线临床试验面临欺诈风险. 本研究详细介绍了检测和防止欺诈参与者的方法,在实施了新的预防策略后成功停止了入学.
科学领域:
- 临床研究方法论临床研究方法论
- 数字健康和远程医疗.
- 研究完整性和研究道德.
背景情况:
- 虚拟临床试验提高了研究的可访问性,但引入了为了经济利益而欺诈参与的风险.
- 涉及伪造身份或资格信息的欺诈性招生在2023年两项链接的在线临床试验中被发现.
- 该研究解决了在线环境中保持研究完整性的挑战.
研究的目的:
- 描述虚拟研究中发现和删除欺诈参与者的过程.
- 详细介绍实施的方法,以防止未来在线临床试验中欺诈性注册.
- 评估实施的欺诈预防策略的有效性.
主要方法:
- 在预查,查和基线阶段对可疑活动指标的分类.
- 实施用于预防欺诈的手动检查列表方法.
- 实施后六个月,对预防欺诈的有效性进行评估.
主要成果:
- 在被发现之前,已招募了10名欺诈参与者.
- 在实施新的欺诈预防措施后,在选阶段,37个个人被确定为欺诈者.
- 在实施强化预防方法后,没有新的欺诈参与者被招募.
结论:
- 手动欺诈预防方法与自动化系统相结合,可以有效地检测和防止在线临床研究中欺诈性招生.
- 在研究阶段识别可疑行为对于减轻虚拟研究入侵至关重要.
- 积极和系统的欺诈检测对于保持虚拟研究的有效性至关重要.
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