在临床试验中代表夏威夷原住民和太平洋岛民个人
Deborah A Taira1,2, Mona Shing Ranken2, Brendan K Seto3
1Daniel K. Inouye College of Pharmacy, University of Hawai'i at Hilo.
JAMA network open
|October 29, 2024
概括
夏威夷原住民和太平洋岛民参与销量最高的药物的临床试验很低或没有证据. 鉴于他们患某些疾病的风险更高,这种代表性不足令人担忧,需要有针对性的宣传和研究.
科学领域:
- 临床药理学 临床药理学
- 卫生公平性健康公平性
- 药物开发 药物开发
背景情况:
- 多样化的临床试验参与对于药物疗效和跨人群安全至关重要.
- 在临床试验中,有关夏威夷原住民和太平洋岛民代表性的数据很少.
- 这项研究解决了了解他们参与高收入药物的试验的差距.
研究的目的:
- 评估2024年全球销售预测最高的10种药物产品临床试验中夏威夷原住民和太平洋岛民的代表性.
- 将他们的参与率与他们在美国人口中的比例进行比较.
主要方法:
- 对2006年至2021年的临床试验数据进行了横截面的二次分析.
- 包含的试验是那些支持美国食品和药物管理局 (FDA) 对前十大预测药物的首次批准的试验.
- 数据分析发生在2024年2月至8月.
主要成果:
- 在这10种药物产品的试验中,夏威夷原住民和太平洋岛民的参与率很低或没有记录.
- 对于60%的药物,他们的参与人数没有被记录.
- 据记录,参与率低于美国人口比例,对某些药物观察到的统计学上显著的代表性不足.
结论:
- 确定了夏威夷原住民和太平洋岛民在主要药物的临床试验中的有限文件和参与.
- 这种代表性不足至关重要,因为这个人口群体面临着这些药物向疾病的更高风险.
- 建议包括在夏威夷等地区建立试验场所,并在这些社区进行市场后研究.
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