监管格局与美国患者要求和临床试验多样性的期望
Elizabeth George1, Alicia Baker McDowell2, Melissa Vozza3
1Patient Diversity, Labcorp, USA.
Contemporary clinical trials communications
|September 24, 2024
概括
美国食品和药物管理局 (FDA) 需要各种临床试验数据才能获得营销许可. 新的立法授权FDA强制制定多样性计划,确保药物开发中的代表性.
科学领域:
- 监管科学 监管科学
- 临床试验管理 临床试验管理
- 健康 公平 卫生 公平
背景情况:
- 美国食品和药物管理局 (FDA) 规定,营销许可申请必须包括代表美国患者群体的数据.
- 外国的临床数据必须反映种族多样化的人口,并遵守良好的临床实践 (GCP).
研究的目的:
- 讨论FDA关于临床试验多样性计划的指导意见.
- 检查FDA对赞助商关于外国临床数据和多样化的参与者入学的期望.
主要方法:
- 分析FDA指导文件,包括"多样性计划,以改善来自代表性不足的种族和民族群体参与者在临床试验中的招生" (2022年4月).
- 审查最近的综合立法,授权FDA要求关键试验的多样性计划.
- 对外国临床研究的监管要求的审查 (21 CFR 312.120).
主要成果:
- 美国食品和药物管理局 (FDA) 预计外国临床数据将具有种族多样性,并根据GCP的合格主要调查员 (PI) 收集.
- 综合立法使FDA能够对第三阶段或关键药物研究制定多样性计划.
- 预计FDA的最新指南将于2023年发布,以反映立法变化.
结论:
- 赞助商必须确保外国临床数据符合多样性和质量标准.
- 多样性计划正在成为临床试验设计和监管提交的关键组成部分.
- 外国数据要求与国内多样性倡议之间的协调对于全面的药物开发至关重要.
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