在乳腺癌临床试验的早期阶段包括患者
A Sinha1, L Barwell2, H Jeffery1
1King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, United Kingdom.
Journal of cancer policy
|July 22, 2024
概括
年龄较大和英语水平有限阻碍了早期临床试验参与. 解决这些障碍对于乳腺癌研究中的公平代表性至关重要.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 健康 公平 卫生 公平
背景情况:
- 在临床试验中,特定患者群体 (例如非高加索族裔,低社会经济地位,年龄较大,神经分化,高BMI) 的代表性不足是一个已有记录的问题.
- 确保多样化的患者代表性对于试验结果来说至关重要,以准确地反映更广泛的人口.
- 早期乳腺癌试验需要检查各种人口和社会经济层面的患者包容性.
研究的目的:
- 在两个早期乳腺癌临床试验中分析患者招募途径.
- 评估这些试验中代表性不足的患者子组的包容性.
主要方法:
- 对乳腺癌研究数据库的审查,以检查两项早期试验中符合资格的患者特征.
- 利用基于患者邮政编码的英语贫困指数 (IMD) 来评估社会经济地位.
主要成果:
- 在392名符合条件的患者中,在2020年9月至2023年5月期间招募了144名 (36.7%).
- 被招募的患者比未被招募的合格患者 (平均年龄为56.0岁) 年轻得多 (平均年龄为49.1岁).
- 语言障碍 (需要口译员) 在被招募的患者 (1名患者) 与未被招募的患者 (24名患者) 相比显著较低. 招募和非招募组之间在IMD,BMI或神经多样性方面没有发现显著差异.
结论:
- 年龄较大和英语流利程度较低仍然是早期临床试验参与的重大障碍.
- 提高意识,培训和提供多语言试验信息的策略是必要的,以提高包容性.
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