Prism Analytic Technologies, 245 Main St., Cambridge, MA, 02142, USA.
Janssen-Cilag B.V., 4837 DS, Breda, The Netherlands.
Ther Innov Regul Sci. 2023 Nov;57(6):1269-1278. doi: 10.1007/s43441-023-00560-y. Epub 2023 Aug 6.
Digital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to reduce the burden on participants, collect outcome data in a real-world setting, and potentially make trial populations more diverse and inclusive. However, DHTs can also be a significant source of electronic waste (e-waste). In recognition of the potential health and environmental impact from DHT use in trials, private and public institutions have recently launched initiatives to help measure and manage this e-waste. But in order to develop sound e-waste management policies, it will be necessary to first estimate the current volume of e-waste that results from the use of DHTs in trials.
A Web Ontology Language (OWL)-compliant ontology of DHTs was created using a list of 500 DHT device names derived from a mixture of public and private sources. The U.S. clinical trials registry, ClinicalTrials.gov, was then queried to identify and classify trials using any of the devices in the ontology. The ClinicalTrials.gov records from this search were then analyzed to characterize the volume and properties of trials using DHTs, as well as estimating the total volume of individual DHT units that have been provisioned (or are planned to be provisioned) for clinical research.
Our ontology-driven search identified 2326 unique clinical trials with a reported "actual" enrollment of 200,947 participants and a "planned" enrollment of an additional 4,094,748 participants. The most-used class of DHTs in our ontology was "wearables," (1852 trials), largely driven by the use of smart watches and other wrist-worn sensors (estimated to involve 149,391 provisioned devices). The most-used subtype of DHTs in trials was "subcutaneous" devices (367 trials), driven by the prevalent use and testing of glucose monitors (estimated to involve 17,666 provisioned devices).
Thousands of trials, involving hundreds of thousands of devices, have already been completed, and many more trials (potentially involving millions more devices) are planned. Despite the great opportunities that are afforded by DHTs to the clinical trial enterprise, if the industry lacks the ability to track DHT use with sufficient resolution, the result is likely to be a great deal of e-waste. A new ontology of DHTs, combined with rigorous data science methods like those described in this paper, can be used to provide better information across the industry, and in turn, help create a more sustainable and equitable clinical trials enterprise.
数字健康技术（DHT）可以促进去中心化试验的实施，从而为减少参与者的负担、在真实环境中收集结果数据以及使试验人群更加多样化和包容性提供机会。然而，DHT 也可能是电子垃圾（e-waste）的重要来源。鉴于 DHT 在试验中的使用可能对健康和环境产生影响，私营和公共机构最近已启动相关倡议，以帮助衡量和管理这种电子垃圾。但是，为了制定合理的电子垃圾管理政策，首先需要估计 DHT 在试验中使用所产生的电子垃圾的当前量。
使用从公共和私人来源混合获得的 500 种 DHT 设备名称列表，创建了符合 Web 本体语言（OWL）的 DHT 本体。然后，查询美国临床试验注册处 ClinicalTrials.gov，以识别和分类使用本体中任何设备的试验。从该搜索中获得的 ClinicalTrials.gov 记录随后进行了分析，以描述使用 DHT 的试验的数量和性质，并估计为临床研究提供（或计划提供）的各个 DHT 设备的总数量。
我们的本体驱动搜索确定了 2326 项独特的临床试验，实际入组人数为 200947 人，计划入组人数为 4094748 人。在我们的本体中，使用最广泛的 DHT 类别是“可穿戴设备”（1852 项试验），这主要是由智能手表和其他腕戴式传感器的使用驱动的（估计涉及 149391 个已配置设备）。在试验中使用最广泛的 DHT 子类型是“皮下”设备（367 项试验），这主要是由流行的葡萄糖监测仪的使用和测试驱动的（估计涉及 17666 个已配置设备）。
数千项试验已经完成，涉及数十万设备，而更多的试验（可能涉及数百万甚至更多设备）正在计划中。尽管 DHT 为临床试验企业带来了巨大的机会，但如果行业缺乏足够的分辨率来跟踪 DHT 的使用情况，结果很可能是大量的电子垃圾。新的 DHT 本体，结合本文中描述的严格的数据科学方法，可以在整个行业提供更好的信息，从而有助于创建更可持续和公平的临床试验企业。
