药物的物理可访问性在国家主办试验FDA批准的试验
Chris J Lee1, Cary P Gross2,3,4, Jennifer E Miller2,5
1Department of Molecular, Cellular and Developmental Biology, Yale University, New Haven, Connecticut.
JAMA internal medicine
|November 17, 2025
概括
低收入和中等收入国家 (LMICs) 的临床试验参与者往往无法及时获得经过美国食品和药物管理局 (FDA) 批准的药物. 这项研究发现,随着时间的推移,LMICs在获得这些重要医疗干预措施方面没有改善.
科学领域:
- 全球卫生平等全球卫生平等
- 药品接入 药品接入 药品接入
- 临床试验伦理学研究
背景情况:
- 伦理准则规定,临床试验中的人群应该从新的干预措施中受益.
- 以前的研究表明,参与美国食品和药物管理局 (FDA) 批准试验的低收入和中等收入国家 (LMICs) 经常在获得测试药物的过程中遇到延迟,这引发了对利用的担忧.
研究的目的:
- 为了调查药物的可访问性,在国家,他们进行了FDA批准的测试.
- 分析这些药物的市场授权和物理可访问性的时间表.
- 通过国家收入水平和地理区域分层研究随时间推移的药物可访问性趋势.
主要方法:
- 对2015年至2018年期间支持FDA批准新药的2期和3期临床试验进行了横截面回顾分析.
- 数据来源于Drugs@FDA数据库,ClinicalTrials.gov和药物监管机构网站.
- 分析范围从2022年11月到2025年1月,重点关注市场授权和物理可访问性时间表.
主要成果:
- 在89个参与国家中,只有14%的人在FDA批准后5年内可以物理访问所有测试药物.
- 在美国以外测试的药物在所有测试国家只能获得24%的时间.
- 高收入国家与中高收入国家 (22%) 和中低收入国家 (13%),相比,高收入国家 (32%) 获得更好的机会,而低收入国家和中低收入国家 (LMIC) 没有随着时间的推移而有所改善. 非洲 (28%) 的接入率最低,西欧 (82%) 的接入率最高.
结论:
- 大多数参与FDA批准试验的国家都无法及时获得他们帮助评估的药物.
- 低收入和中等收入国家 (LMICs) 在获得这些关键医疗干预方面面临着特别的差异.
- 在研究期间,LMICs的药物可访问性没有明显改善,这突显了全球持续的健康不平等.
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