National Institutes of Health, National Institute on Drug Abuse, Bethesda, MD, USA.
Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, USA.
Contemp Clin Trials. 2021 Jan;100:106219. doi: 10.1016/j.cct.2020.106219. Epub 2020 Nov 17.
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.
2015 年,我们提供了临床试验中数字技术的使用概述,包括作为一种方法工具和干预措施的传递机制。当时,临床研究中数字技术的指导和使用都很有限。然而,从那时起,智能手机已经无处不在,数字健康技术也迅速发展。本文提供了对我们早期出版物的更新,并概述了过去五年中技术在临床试验中的使用情况,提供了不同技术整合程度和不同健康状况的例子。数字技术的整合范围从诊断设备中人工智能的应用到使用真实世界的数据(例如,电子健康记录)进行研究招募。临床试验现在可以完全在虚拟环境中进行,无需进行面对面的互动。已发表的大部分研究都表明了数字方法如何改善临床试验的设计和实施。尽管仍然存在挑战,但过去五年的进展令人鼓舞,并且可以通过精心规划克服障碍。