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在泌尿瘤学临床试验中不必要的功能排除标准的流行率
Merrick Bank1, Madison Krischak2, Ted Skolarus3
1Department of Urology, Michigan State University, College of Human Medicine, East Lansing, MI; Department of Urology, University of Michigan, Ann Arbor, MI.
Urologic oncology
|October 11, 2024
概括
许多泌尿瘤学临床试验将患者排除在功能之外,即使治疗没有对的影响. 简化这些标准可以改善试验成功和患者获取.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 腎臟病學 (nephrology) 是一種醫學.
背景情况:
- 临床试验对于癌症治疗的进步至关重要,但招生率很低.
- 包括功能在内的资格标准可以不必要地限制患者池和访问.
研究的目的:
- 在3期泌尿瘤学试验中评估功能适用性标准.
- 为了确定与干预效应相关的这些排除的适当性.
主要方法:
- 使用自然语言处理 (NLP) 来从clinicaltrials.gov (2007-2021) 中提取功能要求.
- 手动编码评估了对功能和GFR计算方法的干预效应.
主要成果:
- 35%的试验有功能限制.
- 41%的脏排除试验涉及没有脏影响的干预措施.
结论:
- 在功能排除和实际干预风险之间存在显著的脱节.
- 标准化标准,根据功能排除患者只有在必要时,可以提高试验的成功,访问和适用性.
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