在血友病临床试验中的种族和种族报告和代表性
Stacey A Fedewa1,2, Leonard A Valentino3, Andee Koo1
1Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.
Blood advances
|March 28, 2024
概括
血友病临床试验中的种族和民族多样性有所改善,但黑人和西班牙裔个人仍然代表不足. 需要制定战略,确保所有患有血友病 (PwH) 的人均平等参与.
科学领域:
- 临床试验多样性 临床试验多样性
- 血液学研究的研究血液学.
- 卫生公平性健康公平性
背景情况:
- 临床试验中的种族和民族代表性对于解决健康差异至关重要.
- 血友病临床试验中的多样性在很大程度上仍未得到检查.
- 了解参与者的人口统计是确保公平结果的关键.
研究的目的:
- 分析血友病 (PwH) 患者临床试验中种族和民族的报道和代表性.
- 使用美国人口普查和血友病治疗中心 (HTC) 数据,比较观察到的参与者人口统计与预期比例.
- 识别随着时间的推移报告和参与的趋势.
主要方法:
- 在clinicaltrials.gov (2007-2022) 登记的PwH干预性临床试验的横截面分析.
- 提取关于试验赞助,参与者数量和年龄的数据.
- 报告的种族/种族数据与美国HTC和国家特定人口普查数据的比较,使用观察到预期的比率 (OER).
主要成果:
- 在129项试验中,52%报告了种族/种族数据,到2017-2022年报告率将增加到100%.
- 白人参与者占65.8%,其次是亚裔 (22.8%),西班牙裔 (5.1%) 和黑人 (3.9%).
- 观察到预期的比例显示,与美国人口普查数据相比,黑人和西班牙裔个体的代表性明显低,亚裔个体的代表性过高.
结论:
- 虽然在血友病试验中报告种族和种族的情况有了显著的改善,但黑人和西班牙裔人口仍然存在严重的代表性不足.
- 观察到预期的比率突显出参与度的严重差异.
- 利益相关者必须实施有针对性的战略,以增强多样性,并确保在未来的血友病临床试验中得到公平的代表.
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