在FDA批准的药物试验中缺乏代表
medRxiv : the preprint server for health sciences
|January 31, 2024
概括
食品和药物管理局 (FDA) 批准药物的临床试验数据经常缺乏必要的性别,种族和种族信息. 这种报告不足影响了批准药物的试验结果的概括性.
科学领域:
- 临床试验 临床试验
- 药物批准过程 药物批准过程
- 健康 公平 卫生 公平
背景情况:
- 随机对照试验 (RCT) 数据的概括性对于食品和药物管理局 (FDA) 药物批准过程至关重要.
- 准确报告人口统计数据,包括性别,种族和种族,对于确保试验的代表性至关重要.
- 以前的FDA和Clinicaltrials.gov的授权并没有完全解决临床试验中人口统计数据报告不足的问题.
研究的目的:
- 在支持FDA批准药物的临床试验中评估性别,种族和种族数据的完整性.
- 为了比较FDA批准的试验与非FDA批准的试验中的数据报告.
主要方法:
- 审查了最近获得FDA批准的100种药物.
- 从clinicaltrials.gov.gov.gov.gov 抽象支持临床试验数据进行抽象.
- 在FDA批准的试验中报告的人口统计数据与同一年的大小相似的非FDA批准的试验进行了比较.
主要成果:
- 40%的FDA批准的试验缺乏种族/种族信息.
- 24%的FDA批准的试验缺乏性别信息.
- 在支持FDA药物批准的试验中,在人口统计数据中发现了显著的差距.
结论:
- 尽管有任务,但在导致FDA药物批准的试验中,大量缺失的性别和种族/种族数据仍然存在.
- 这种数据缺口可能会限制批准药物的概括性和公平性.
- 需要进一步努力,以确保在临床试验中全面收集和报告人口统计数据.
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