Academic Journal
Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies
| العنوان: | Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies |
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| المؤلفون: | Hey, Spencer Phillips, Dellapina, Maria, Lindquist, Kristin, Hartog, Bert, LaRoche, Jason |
| المصدر: | Therapeutic Innovation & Regulatory Science ; volume 57, issue 6, page 1269-1278 ; ISSN 2168-4790 2168-4804 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2023 |
| الوصف: | Background 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. Materials and Methods 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. Results 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). Conclusion Thousands of trials, involving hundreds of thousands of devices, have already been completed, and ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1007/s43441-023-00560-y |
| DOI: | 10.1007/s43441-023-00560-y.pdf |
| DOI: | 10.1007/s43441-023-00560-y/fulltext.html |
| الاتاحة: | http://dx.doi.org/10.1007/s43441-023-00560-y https://link.springer.com/content/pdf/10.1007/s43441-023-00560-y.pdf https://link.springer.com/article/10.1007/s43441-023-00560-y/fulltext.html |
| Rights: | https://creativecommons.org/licenses/by/4.0 ; https://creativecommons.org/licenses/by/4.0 |
| رقم الانضمام: | edsbas.ADAD8798 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1007/s43441-023-00560-y |
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