当随机化发生严重错误时:随机化的重大失败示例和避免失败的策略
Lisa N Yelland1,2, Kylie M Lange1,3, Sabine Braat4,5
1Women and Kids Theme, South Australian Health and Medical Research Institute, PO Box 11060, Adelaide, SA, 5001, Australia.
临床试验中的重大随机化错误可以使结果无效,导致撤回. 本研究详细介绍了常见的错误,并提供了预防这些错误的实际指导,以确保试验的完整性.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 研究诚信研究诚信
背景情况:
- 随机化对于临床试验的有效性至关重要.
- 随机化中的错误可能会损害试验的完整性,并导致撤回.
- 从过去的随机化失败中学习对于未来的试验设计至关重要.
研究的目的:
- 描述临床试验中随机化主要失败的例子.
- 为避免在未来的试验中出现这样的错误提供实际指导.
主要方法:
- 将重大随机化失败定义为影响许多参与者的错误.
- 审查了作者经验和出版文献,包括Retraction Watch数据库.
- 通过专家共识开发实践要点.
主要成果:
- 确定了七种主要的随机失败类型:错误的计划使用/排序,长度不足,集群处理错误,错误的治疗分配,有缺陷的方案设计和适应性随机编程错误.
- 提出了实践要点,包括文件,员工培训和试验前测试.
- 强调在发生错误时需要透明度.
结论:
- 主要随机化失败对临床试验有效性构成重大风险.
- 积极的策略和严格的测试对于防止随机化错误至关重要.
- 报告随机化失败时需要提高透明度.
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