在2000-2023年间,血液恶性瘤试验的报告和招生差异
Inna Y Gong1,2, Bahar Rafinejad-Farahani1, Haris Majeed1
1Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Leukemia & lymphoma
|November 3, 2025
概括
血液性恶性瘤临床试验的多样性仍然是一个挑战. 黑人和西班牙裔患者的代表性不足,这凸显了需要更好的人口统计报告和代表性目标的需要.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 健康差异 在健康上的差异
背景情况:
- 尽管努力改善多样性,但血液恶性瘤 (HM) 的临床试验继续显示持续的差异.
- 在HM临床试验中,代表性不足的种族和民族群体的招生落后于一般人口的基准标准.
研究的目的:
- 评估人口统计报告 (种族和族裔) 和2000年至2023年美国II-III期HM临床试验参与者代表性的趋势.
- 将招生数据与监测,流行病学和最终结果 (SEER) 基准进行比较,以确定特定的差异.
主要方法:
- 综合审查了1230个美国II-III期HM临床试验,涉及149,434名参与者.
- 对人口报告率和参与者人口统计数据的分析,比较2016年之前和之后启动的试验,并按赞助商类型 (NIH,机构,行业) 分类.
主要成果:
- 在59%的试验中报告了种族,在40%的试验中报告了种族,在2016年之后开始的试验中报告的情况有显著改善.
- 黑人和西班牙裔人群总是代表性不足,特别是在多发性骨髓瘤和急性淋巴细胞白血病试验中.
- 与机构和行业试验相比,NIH赞助的试验显示报告人口统计数据的可能性更高,并招募了更多的黑人参与者.
结论:
- 在血液恶性瘤临床试验中,种族和民族报告和参与者代表性的显著差异仍然存在.
- 对人口统计报告和代表性目标的可执行授权对于确保公平获取和试验结果的普遍性至关重要.
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