Digitalisation in Clinical Trials: trends in connected sensor technology use

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.