Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

Abstract

BackgroundThe need for a new style of clinical trials, called decentralized clinical trials (DCTs), has been increasing as they do not depend on physical visits to clinical sites. DCTs are expected to provide a new opportunity to patients who cannot participate in a clinical trial due to geographical and time limitations. For the adoption of DCTs, it is essential that medical devices with Internet of Medical Things (IoMT) and Internet of Health Things (IoHT) based technologies are developed and commercially adopted. In this study, we aimed to identify the regulatory considerations when IoMT/IoHT-based technologies are used in DCTs or products developed using DCTs.MethodTo understand the study and development field of IoMT/IoHT comprehensively and panoramically, relevant papers published in Web of Science were searched online. Subsequently, a citation network was obtained and characterized as a cluster using a text mining method to identify IoMT/IoHT-based technologies expected to be utilized in DCTs or products developed using DCTs.Result and DiscussionUpon analysis of the top 15 clusters and subsequent 51 sub-clusters, we identified the therapeutic areas (psychology, neurology) and IoMT/IoHT-based technologies (telemedicine, remote monitoring, and virtual reality) that are expected to be used in DCTs. We also identified several considerations based on the current regulatory guidance.ConclusionIoMT/IoHT-based technologies that are expected to be used or products developed using DCTs and key considerations made when they are used in DCTs were identified. The considerations could encourage conducting DCTs using IoMT/IoHT-based technologies.

Implementation status and consideration for the globalisation of decentralised clinical trials: a cross-sectional analysis of clinical trial databases

“…A previous study reported on IoHTs that are expected to be used in DCTs through bibliographic citation network analysis and text mining. 4 The results of using clinical trial databases as the source of information are consistent with those of the previous study. As shown in table 1 , the largest number of trials with DCT components were related to diseases of the circulatory system (124 studies), followed by endocrine, nutritional and metabolic diseases (70 trials), diseases of the nervous system (61 studies) and mental and behavioural disorders (46 studies).…”

“…A previous study reported on IoHTs that are expected to be used in DCTs through bibliographic citation network analysis and text mining 4. The results of using clinical trial databases as the source of information are consistent with those of the previous study.…”

“…We previously studied the development trends of the Internet of Medical Things (IoMTs)/Internet of Healthcare Things (IoHTs), which are expected to be used in DCTs, through a bibliographic citation network analysis and text mining. We identified the relevant regulatory considerations and the disease areas and technical fields in which DCT is expected to be widely used 4. Rogers et al quantitatively and qualitatively evaluated published data on DCT design and implementation, and de Jong et al reported on the implementation of decentralised activities in registered clinical trials 5 6.…”

“…We identified the relevant regulatory considerations and the disease areas and technical fields in which DCT is expected to be widely used. 4 Rogers et al quantitatively and qualitatively evaluated published data on DCT design and implementation, and de Jong et al reported on the implementation of decentralised activities in registered clinical trials. 5 6 However, it is necessary to comprehensively assess the implementation status of existing DCTs to identify and address the challenges associated with their global conduct.…”

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

“…Hence, the adoption of DCTs was challenging. By February 2022, only two countries (Denmark and Switzerland) had digital clinical trials included in their guidelines 15. In-depth deliberation of the topic was initiated in 2010 with a European Medicines Agency (EMA) position paper covering electronic source data and data transcribed to electronic data collection tools and was further detailed in 2023 in the Guideline on computerised systems and electronic data in clinical trials 16.…”