Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations
Sato et al.
The finding, in our words
Citation network and regulatory analysis shows that Internet of Medical Things technologies, particularly telemedicine and remote monitoring across neurology and psychology, are increasingly positioned for adoption in decentralised clinical trials under evolving regulatory frameworks.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The review highlights that decentralized clinical trials can improve inclusivity and efficiency by overcoming geographical and logistical barriers through remote digital technologies, though challenges remain regarding data security, privacy, and regulatory standardisation.
The narrative review identified gaps in sustainability assessment within current DCT frameworks, noting that environmental impacts such as carbon footprint and disposal of sensors and investigational medicinal products are not comprehensively addressed, highlighting a need for more complete guidance.
Singh et al., Clinical pharmacology and therapeutics (paywalled) · source ↗
The study observed favourable trends in the accrual of participants residing far from the site and those from underrepresented groups following the implementation of a decentralised clinical trial program.
The Australian Teletrial Programme improved patient access to trials and workforce capability through harmonised processes and training, but broader implementation is limited by workforce turnover, complex approvals, and variable leadership engagement. This highlights that systemic policy and governance support are critical for the sustainable integration of decentralised trial models.
Sabesan et al., Journal of telemedicine and telecare (paywalled) · source ↗
A fully remote decentralised clinical trial in Danish adults with type 2 diabetes demonstrated operational feasibility with rapid recruitment, high retention (87 percent), and excellent adherence to continuous glucose monitoring (95 percent achieving ≥70 percent data coverage) and telemedicine visits (97 percent). Activity tracker adherence was poor (12 percent) due to technical issues, but remote safety monitoring was effective with no unexpected adverse events, supporting the viability of remote diabetes management.