2004年至2020年3期瘤学试验中的子组分析的差异化治疗效应
Alexander D Sherry1, Andrew W Hahn2, Zachary R McCaw3,4
1Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.
JAMA network open
|March 28, 2024
概括
瘤学试验中的子组分析往往缺乏可解释的森林地块和可信的对差异性治疗效应的说法. 大多数声明的质量很低,需要谨慎和改进子组分析报告的方法.
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:
- 亚组分析在瘤学中至关重要,用于评估差异化治疗效应,并为监管决策提供信息.
- 然而,在已发表的瘤学试验中,这些分析的质量,可解释性和可信性尚未得到充分理解.
- 有限的理解需要对报告子组分析的当前做法进行评估.
研究的目的:
- 评估用于瘤学临床试验的森林地块的可解释性和可信性.
- 评估来自瘤学子组分析的关于差异性治疗效应的说法的有效性.
主要方法:
- 一项横截面研究分析了2021年之前发表的随机第三期瘤学试验,通过ClinicalTrials.gov.gov进行选.
- 通过点估计和适当的x轴尺度来评估森林地块的可解释性.
- 差异化治疗效果声明的可信性使用标准化仪器进行了评价,并记录了多重性测试和相互作用测试.
主要成果:
- 在785项试验中,379项 (48%) 报告了子组分析;43%的森林地块缺乏必要的视觉元素.
- 在评估的4148个子组中,只有1个试验 (0.3%) 控制多重测试.
- 93%的差异化治疗效果声明 (共101项) 被评为低或非常低的可信度,其中53%缺乏相互作用测试.
结论:
- 近一半的第三期瘤学试验包括子组分析,但报告质量往往很差,阻碍了解释.
- 大多数关于差异化治疗效应的说法缺乏足够的证据和可信性,特别是在未达到主要终点的试验中.
- 在瘤学研究中,对子组分析进行改进的方法和报告标准至关重要.
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