在获得行业资助的症治疗药物试验I-IV期干预试验的不平等
Robert Hoepner1, Alejandro Xavier León Betancourt1, Stefanie Marti1
1Department of Neurology, Inselspital, Bern University Hospital, Bern, Switzerland.
Epilepsia open
|June 20, 2025
概括
全球药试验集中在高收入国家,非洲和地中海东部等地区的代表显著不足. 这突显了全球临床研究分布和患者获得临床研究的严重不平等.
科学领域:
- 全球健康 全球健康
- 临床药理学 临床药理学
- 神经学 神经学
背景情况:
- 药物安全性和疗效的临床试验被认为是普遍适用的,但在全球分布上不均.
- 药试验对于治疗进步至关重要,在不同的地理和社会经济环境中并不均等地代表.
研究的目的:
- 分析治疗的I-IV期临床药物试验的全球分布.
- 调查试验地点分布与主要的人口和流行病学因素之间的相关性.
主要方法:
- 来自行业资助的干预性症药物试验的数据来源于clinicaltrials.gov.gov.
- 试验地点分布与流行病学,地理,社会经济和人类发展指数 (HDI) 数据进行了分析.
主要成果:
- 在69个国家的459项试验中,大多数地点位于高收入国家,HDI非常高.
- 低收入国家和 HDI 较低的国家的代表显著不足.
- 世卫组织非洲和东地中海地区的试验场所显示,相对于人口,发病率或流行率,代表性不足40至145倍.
结论:
- 根据人口规模和疾病负担,临床试验地点分布存在显著的不平等.
- 迫切需要更公平的试验安置策略,将疾病流行病学和人口多样性纳入其中.
- 确保所有受影响人群的代表性对于全球治疗进步至关重要.
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