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在基于美国学术研究中心的多中心临床研究中使用分散的研究技术

Mollie R Cummins^1,2, Jeri Burr¹, Lisa Young¹

¹University of Utah, Salt Lake City, UT, USA.

Journal of clinical and translational science

|January 17, 2024

概括

学术研究组织广泛采用了2020年后临床试验的分散技术. 电子IRB,eSource和CTMS等基本工具几乎是普遍存在的,而远程医疗和ePRO等其他工具则显示出大量使用.

科学领域:

临床研究信息学临床研究信息学
分散的临床试验分散的临床试验

背景情况:

随着COVID-19的流行,研究中远程参与技术的采用加速了.
非常需要评估当前的去中心化做法,并为研究,教育和运营开发强大的基础设施.

研究的目的:

检查学术研究组织 (ARO) 协调的临床研究研究中采用去中心化技术的情况.

主要方法:

该研究分析了44项由美国三个数据协调中心协调的临床研究,这些研究是在2020年或之后启动的.
收集了在这些全国招募和注册研究中使用的去中心化技术的数据.

主要成果:

所有44项研究都纳入了去中心化技术,广泛采用电子机构审查委员会 (eIRB),eSource和临床试验管理系统 (CTMS) (98-100%).
通常采用的技术包括电子签名 (73%),在线支付门户 (59%),电子患者报告结果 (ePRO) (53%),交互式响应技术 (IRT) (50%),远程医疗 (43%) 和电子同意 (eConsent) (41%).
不太常见的技术是可穿戴设备 (16%) 和在线招聘门户 (11%),而直接向患者的门户和家庭卫生护士门户很少使用 (2%).

结论:

所有研究的临床试验都采用了某种形式的去中心化技术,这表明其采用范围比之前报告的更广泛.
技术采用程度可能受到机构IT和信息基础设施和支持的影响.
学术研究组织必须确保有足够的基础设施和信息人员来管理与分散技术相关的需求,责任和挑战.

关键词:

生物医学研究的研究.临床研究信息学数据协调中心数据协调中心分散式的分散式研究.分散的试验是分散的试验.数字健康数字健康信息学是一个信息学领域.

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