许可证翻译费用阻碍了临床试验的招生
Maria A Velez1, Beth A Glenn2,3,4,5, Maria Garcia-Jimenez1,2,6
1Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.
Nature
|August 2, 2023
概括
癌症临床试验同意文件的翻译成本可能会阻碍英语水平有限的患者参与. 没有行业赞助的研究显示这些患者的注册率和转换率较低.
科学领域:
- 癌症学
- 临床试验
- 医疗公平
背景情况:
- 来自少数种族和族群的患者参与美国癌症临床试验的比例很低.
- 在这些患者群体中,英语能力有限是常见的,可能会造成沟通障碍.
研究的目的:
- 调查是否同意文件的翻译成本是将英语水平有限的患者纳入癌症临床试验的障碍
- 在行业赞助和非行业赞助的试验中比较英语水平有限的患者的入学率和翻译率.
主要方法:
- 在一个大型癌症中心对12000多起同意事件的分析.
- 在行业赞助和非行业赞助的研究中,同意文件翻译和患者入学率的比较.
- 对需要翻译同意文件的患者进行评估.
主要成果:
- 在没有行业赞助的研究中,与行业赞助的研究相比,英语水平有限的患者的同意事件比例约为一半.
- 在签署同意文件的患者中,非行业赞助研究的患者将其文件翻译成主要语言的可能性大约为一半.
- 这表明基于研究赞助的访问和翻译服务存在显著差异.
结论:
- 在非行业赞助的癌症试验中,翻译同意文件的成本可能是患者纳入的重大,可修改的障碍.
- 应对翻译费用可以提高英语水平有限的患者在临床研究中的公平参与.
- 确保翻译的同意文件是提高癌症临床试验多样性的关键.
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