良好的统计监测:一种灵活的开源工具,用于检测临床试验中的风险
George Wu1, Spencer Childress2, Zhongkai Wang2
1Gilead Sciences Inc., 333 Lakeside Dr, Foster City, CA, 94404, USA. George.Wu@gilead.com.
Therapeutic innovation & regulatory science
|May 9, 2024
概括
良好的统计监测是临床试验的一个新的开源R包. 它通过灵活的数据分析和报告来实现积极的风险检测和减轻,提高质量管理.
科学领域:
- 临床试验的管理管理.
- 监管科学是一种监管科学.
- 在医疗保健中的数据分析.
背景情况:
- 建议在临床试验中进行基于风险的质量管理.
- 基于风险的监测对于早期发现试验风险至关重要.
- 临床试验风险分析的开源工具有限.
研究的目的:
- 为了引入良好的统计监测,一个开源的R包.
- 为临床试验中进行端到端风险分析提供灵活有效的工具.
- 支持基于风险的质量管理策略.
主要方法:
- 由统计学家,数据科学家和临床专家共同开发.
- 一个支持各种格式数据映射的R包.
- 包括对12个关键风险指标的评估和交互式报告.
主要成果:
- 该软件包在GitHub上免费提供.
- 能够进行主动监测和定制风险评估.
- 结果可导出,并可在交互式报告中可视化.
结论:
- 良好的统计监测有助于对关键风险进行统计监测.
- 它支持基于风险的综合质量管理战略.
- 该开源解决方案赋予临床研究团队权力.
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