需要在淋巴瘤中进行关键临床试验的人口代表性
Mycal Casey1, Lorriane Odhiambo2, Nidhi Aggarwal3
1Department of Internal Medicine, Medical College of Georgia at Augusta University, Augusta, GA.
Blood
|June 26, 2023
概括
在淋巴瘤临床试验中,种族和地理差异仍然存在. 黑人,西班牙裔和女性患者的代表性不足,这限制了新癌症治疗方法对所有人群的适用性.
科学领域:
- 在瘤学瘤学.
- 临床试验多样性 临床试验多样性
- 健康差异 在健康上的差异
背景情况:
- 癌症治疗的进步改善了淋巴瘤的治疗结果.
- 确保获得新型治疗方法的平等机会,需要在临床试验中招募多样化的患者.
- 在癌症护理方面仍然存在显著的健康差异,特别是在少数群体中.
研究的目的:
- 评估淋巴瘤随机对照试验 (RCT) 中患者的人口和地理代表性.
- 将试验参与者的多样性与不同人群的实际疾病负担进行比较.
- 为了确定获得淋巴瘤临床试验的差异.
主要方法:
- 经过审查的食品和药物管理局数据库,clinicaltrials.gov,以及淋巴瘤药物批准的初级手稿和RCT数据.
- 分析了人口统计数据 (种族,性别) 和参与试验的地理分布.
- 与疾病发病率,保险状况和种族人口统计相关的测绘试验访问.
主要成果:
- 与疾病负担相比,黑人,西班牙裔和女性患者在淋巴瘤RCT中显著不足.
- 在这些关键试验中,白人和男性患者的比例过高.
- 地理分析显示,高死亡率和少数群体地区的试验访问有限,特别是美国南部的古典霍奇金淋巴瘤.
结论:
- 关键性淋巴瘤临床试验显示出明显的种族和地理错误陈述.
- 目前的试验分布可能无法确保所有患者群体均获取.
- 纠正招生差异对于在不同人群中概括治疗效益至关重要.
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