年龄和性别比率的量化测量 新药试验和目标人群之间的差异
Miquel Serra-Burriel1, Paul Schlossmacher2,3, Kerstin Noelle Vokinger2,3
1Epidemiology, Biostatistics, and Prevention Institute, University of Zurich, Zurich, Switzerland.
Clinical pharmacology and therapeutics
|February 2, 2026
概括
临床试验往往低于女性和老年人. 这项研究发现,试验参与者比一般患者人群年轻,女性较少,这影响了药物的安全性和有效性.
科学领域:
- 临床药理学 临床药理学
- 药物开发 药物开发
- 卫生公平性健康公平性
背景情况:
- 临床试验对于评估新药的安全性和有效性至关重要.
- 特定的人口特征,如年龄和性别的代表性不足,可能导致药物益处-危害概况的差异.
- 确保多样化的参与者代表对于公平的医疗保健结果至关重要.
研究的目的:
- 量化临床试验群体和FDA批准药物的目标患者群体之间的年龄和性别比率的差异,从2011-2022年.
- 根据疾病特征识别人口代表性不足的模式.
主要方法:
- 利用FDA数据库进行药物和关键试验识别.
- 从clinicaltrials.gov.gov的平均年龄和性别比率数据中提取了数据.
- 将试验指示与全球疾病负担研究中的疾病患病率进行了匹配.
主要成果:
- 分析了458种药物和773项关键试验.
- 试验人群平均比目标人群年轻4.8岁,女性人数比目标人群少4.3个百分点.
- 根据疾病人口的平均年龄,年龄和性别的代表性有很大差异,年轻人对老年疾病进行试验,反之亦然.
结论:
- 在临床试验参与者和一般患者群体之间存在显著的年龄和性别比差异.
- 在临床试验中改善人口代表性是必要的,以提高药物安全性和有效性.
- 优化试验招生的建议包括将年龄和性别目标定制为特定疾病的人口统计数据.
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