| dc.description.abstract | Objective. Connected sensor technologies are remote measurement technologies that offer an
objective measure of patients’ certain symptoms in their daily routine. Although there is an
interest in implementing these technologies into clinical trials, adoption has been slow.
Currently, there is no complete overview of connected sensor technology use for clinical drug
development, analyzing the studies by the technology, year, study phase, endpoint positioning,
and disease area. This overview can provide insight into the effects of different events and
serve as a basis for future analysis.
Methods. Studies were selected from 2 sources: the DiMe Library of Digital Endpoints and
literature indexed in PubMed. Studies in DiMe Library in which product type was indicated as
“drug” or “biologic” were included. A search query was developed, and the resulting articles
were screened by their titles, abstracts, and text according to the inclusion criteria. Data
regarding study registry year, connected sensor technology, digital clinical measure, the
indication of the test drug, study phase, and endpoint positioning was extracted, and trends
were compared in aggregate and over time.
Results. 71 studies were identified, 63 from the DiMe library, and 8 from the literature review.
Activity monitors were the most used devices (71.8%) and were the only devices observed in
2005-2014. The next most used devices were continuous glucose monitors (14.1%) and heart
activity monitors (5.6%). Interest in phase 4 studies in 2015-17 was observed to shift towards
phase 2 studies, the most common study phase (36.6%). More than half of the studies used
connected sensor technologies to support secondary endpoints (56.3%). The most commonly
addressed disease group was diseases of the nervous system (19.7%), followed by diseases of
the respiratory system (18.3%), endocrine diseases (14.1%), and diseases of the circulatory
system (12.8%). Most of the indicated conditions required long-term disease management.
Conclusion. The use of connected sensor technologies in clinical trials was already an ongoing
process for a long time. We conclude that multiple factors are contributing to increasing
interest. Major factors are increased regulatory guidance and acceptance and acceleration by
the COVID-19 pandemic. In the coming years, a growing interest is expected in digital measures
that offer objective measurement of established endpoints, increasing the knowledge and
regulatory maturity in the domain. Once the quality standards and acceptance by all the
industry stakeholders are established, a steep increase in innovative digital endpoints may be
observed. | |
