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一个模板,用于编写统计分析计划
Gary Stevens1, Shawn Dolley2, Robin Mogg3
1DynaStat Consulting, Inc., 119 Fairway Court, Bastrop, TX, 78602, USA.
Contemporary clinical trials communications
|June 30, 2023
概括
在临床研究设计的早期完成统计分析计划 (SAP) 可以优化样本大小,识别偏差并提高严格性. 这确保了强大的研究协议,并防止p-hacking可靠的试验结果.
科学领域:
- 生物统计学 生物统计学
- 临床试验设计 临床试验设计
- 研究方法研究方法研究方法学
背景情况:
- 主要调查人员往往无法获得生物统计学家或生物统计学培训.
- 经常没有对及时统计分析计划 (SAP) 的要求.
- 早期完成SAP对于识别设计缺陷和改进协议至关重要.
研究的目的:
- 为临床研究设计提供一个全面的协议模板.
- 为统计分析计划 (SAP) 开发提供最佳实践方法.
- 为各级统计学家提供指导,帮助他们创建强大的SAP.
主要方法:
- 来自生物统计学从业人员的最佳实践方法的汇编.
- 包括SAP部分的详细定义和各种示例.
- 开发一个有序的SAP章节集体.
主要成果:
- 早期的SAP完成识别了设计或实施的弱点.
- SAP 改进了协议,减少了 p 黑客攻击,并使同行审查成为可能.
- 同时完成SAP和协议优化了样本大小和严谨性.
结论:
- 一个结构良好的SAP对于严格的临床试验设计至关重要.
- 展示的模板有助于为统计学家创建有效的SAP.
- 早期和全面的SAP开发可以提高研究的完整性和成果.
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