适应变化:疼痛管理协作室关于修改统计分析计划的经验和建议
Qilu Yu1, Steven Z George2, Tassos C Kyriakides3
1Office of Clinical & Regulatory Affairs, National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health, Bethesda, MD 20892, United States.
Pain medicine (Malden, Mass.)
|November 8, 2024
概括
在数据锁定之前,对临床试验的统计分析计划 (SAP) 变更是可以接受的. 记录这些修改的理由和批准,确保了研究的透明度和严格性.
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:
- 临床试验的最佳实践要求在分析之前完成统计分析计划 (SAP).
- 关于可接受的SAP修改及其文档的指南有限.
研究的目的:
- 评估统计分析计划 (SAP) 信息的处理以及实用临床试验 (PCT) 的变化.
- 了解正在进行的试验中的SAP修改的文档和审批流程.
主要方法:
- 在疼痛管理协作室对12项实用临床试验 (PCT) 的调查.
- 评估SAP细节,计划分析,赞助商要求,模板,出版计划,变更,文档和试验注册表更新.
主要成果:
- 所有PCT都在协议中详细介绍了初级结果SAP;大多数包括二级/三级结果.
- 大多数PCT在数据锁定之前,在启动后修改了SAP (例如样本大小,设计,分析方法),通常是由于COVID-19.
- 所有记录在案的变更与理由,主要研究员/生物统计学家的签名,监督机构的批准.
结论:
- SAP修改是可以接受的,直到数据锁定/解锁.
- 透明的SAP变更文件,包括理由和批准,对于研究严谨性至关重要.
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