在临床试验中使用数字技术：当前和未来的应用

摘要(中文译文)

2015年，我们概述了数字技术在临床试验中的应用，既作为方法学工具，也作为实施干预措施的机制。当时，数字技术在临床研究中的指导有限，应用也有限。然而，自那以后，智能手机已无处不在，数字健康技术迅猛发展。本文对我们此前的发表进行了更新，并概述了过去五年中技术如何在临床试验中得到应用，提供了具有不同技术整合水平以及针对不同健康状况的示例。数字技术的整合范围从将人工智能纳入诊断设备，到利用真实世界数据（如电子健康记录）进行研究招募。如今临床试验可以完全以虚拟方式进行，无需面对面互动。大量已发表的研究展示了数字方法如何改善临床试验的设计与实施。尽管挑战依然存在，但过去五年的进展令人鼓舞，通过精心规划，这些障碍是可以克服的。

Abstract

In 2015, we provided an overview of the use of digital technologies in clinical trials, both as a methodological tool and as a mechanism to deliver interventions. At that time, there was limited guidance and limited use of digital technologies in clinical research. However, since then smartphones have become ubiquitous and digital health technologies have exploded. This paper provides an update to our earlier publication and an overview of how technology has been used in the past five years in clinical trials, providing examples with varying levels of technological integration and across different health conditions. Digital technology integration ranges from the incorporation of artificial intelligence in diagnostic devices to the use of real-world data (e.g., electronic health records) for study recruitment. Clinical trials can now be conducted entirely virtually, eliminating the need for in-person interaction. Much of the published research demonstrates how digital approaches can improve the design and implementation of clinical trials. While challenges remain, progress over the last five years is encouraging, and barriers can be overcome with careful planning.

如何引用

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