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评估MEL-SELF试验分析患者主导的早期黑色素瘤监测缺失结果数据方法:模拟研究
Ellie Medcalf1, Robin M Turner2, David Espinoza3
1Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Contemporary clinical trials
|December 17, 2025
概括
对于缺少结果数据的黑色素瘤试验,检索掉队 (RD) 归算将偏差从零最小化,而跳转到参考 (J2R) 归算将偏差向零最小化.
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
- 医学研究 医学研究
背景情况:
- 完整病例分析 (CCA) 是一种常见但潜在偏见的方法,用于处理临床试验中缺少的结果数据.
- 解决缺失的非随机 (MNAR) 数据的先进方法未得到充分利用.
研究的目的:
- 在模拟黑色素瘤监测试验中评估六种不同缺失数据处理方法的性能.
- 在各种缺失数据场景下,比较常用的方法 (CCA,MMRM,MI) 与较新的方法 (RD,J2R,TM).
主要方法:
- 一项基于MEL-SELF试点试验的模拟研究,用于早期黑色素瘤患者主导的监测.
- 评估完整案例分析 (CCA),重复测量混合模型 (MMRM),多重推算 (MI),检索掉落 (RD) 推算,跳到参考 (J2R) 推算和修剪平均值 (TM).
- 场景包括治疗效果的大小,失踪率和失踪假设 (共48个场景).
主要成果:
- 在MNAR条件下,治疗效果小到中等,所有方法都显示出偏差. 修剪平均值 (TM) 和CCA分别表现出最偏向于和偏离零值,精度和功率较低.
- 跳转至参考 (J2R) 归算在偏向于零的方法中表现最好,显示最小偏差,高精度和良好的覆盖率.
- 在偏离零值的方法中,检索失效 (RD) 归算表现最好,表现出小偏差,良好的精度和足够的覆盖.
结论:
- 在非随机缺失结果的黑色素瘤监测试验中,RD归算产生了最少偏离零的偏差.
- 在这个模拟研究中,J2R归算提供了对零值的最小偏差.
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