实施现状和对分散临床试验全球化的考虑:对临床试验数据库的横截面分析
Takahiro Sato1,2, Shota Mizumoto2, Midori Ota2
1Astellas Pharma Inc, Tokyo, Japan 3b20704@ed.tus.ac.jp.
BMJ open
|October 11, 2023
概括
分散临床试验 (DCT) 正在迅速增加,特别是在心血管疾病方面,数字患者监测是其中的一个关键组成部分. 需要国际指导方针来促进全球DCT的实施.
科学领域:
- 临床研究方法论临床研究方法论
- 数字健康创新数字健康创新
- 医疗保健系统分析分析
背景情况:
- 分散临床试验 (DCT) 正在通过整合远程患者参与技术来改变传统研究.
- 了解DCT的当前趋势和组件对于优化其实施和扩大其覆盖范围至关重要.
研究的目的:
- 分析目前分散临床试验 (DCT) 的现状.
- 确定促进DCT实施的关键组件.
- 检查美国和日本DCT的趋势.
主要方法:
- 进行了DCT的横截面分析.
- 数据来自clinicaltrials.gov,日本临床试验注册表和日本临床试验信息.
- 试验被分类为四个DCT组件:远程医疗,家庭医疗保健,患者直接服务和医疗保健物联网 (IoHTs).
主要成果:
- 自2020年以来,DCT的数量每年显著增长.
- 心血管疾病试验是最常见的,数字患者监测是最常用的组件.
- 大多数DCT (超过80%) 在一个国家内进行,只有9.2%跨越多个地区.
结论:
- 人们越来越多地采用DCT,特定组件和治疗领域的实施率更高.
- 该研究强调,需要制定国际共识指导方针,以鼓励多区域的DCT.
- 进一步的研究和标准化对于DCT的全球发展至关重要.
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