在情节中迷失:在Kaplan-Meier在III期瘤学试验的情节中缺少视觉元素
Alexander D Sherry1, Pavlos Msaouel2,3, Ramez Kouzy1
1Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
The oncologist
|June 2, 2024
概括
卡普兰-梅尔曲线中缺少的视觉元素在瘤学试验中很常见,影响数据透明度. 为了更好地解释和重现临床试验结果,需要进行改进.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 卡普兰-梅尔 (KM) 曲线对于在临床试验中可视化生存数据至关重要.
- 在KM图表中缺少视觉元素 (MVE) 可能导致数据的错误表示和透明度降低.
研究的目的:
- 从III期瘤学试验中评估KM图片中MVE的流行率和特征.
- 评估替代终点的KM曲线的完全可解释性.
主要方法:
- 来自641个III期瘤学试验的KM图片的系统评估.
- 定义MVE为不完整的y轴范围或在风险表中缺失的数字.
- 基于受审查的患者数据和间隔对应的替代终点KM曲线的评估可解释性.
主要成果:
- 18%的试验 (116/641) 在KM曲线中表现出MVE.
- 行业赞助,更大的试验规模和最近的出版与较低的MVE赔率相关.
- 只有3%的试验 (15/574) 提供可解释的替代终点KM图.
结论:
- 在瘤学研究中的KM曲线的质量和可解释性方面需要显著改进.
- 在KM图表中解决MVE对于提高透明度,可复制性和数据完整性至关重要.
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