Global Trends and Disparities in Clinical Trials of Digital Health Interventions-Analyzing Data from the WHO ICTRP

Objective Digital health interventions (DHIs) have emerged as transformative tools in healthcare, enhancing effectiveness, accessibility, personalization, and safety. Prior studies on digital technology trials, mainly from ClinicalTrials.gov, often included non-intervention uses. In contrast, this study leverages the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) for a more comprehensive dataset and focuses exclusively on digital health interventions. The study aims to identify and characterize registered DHIs trials from the WHO ICTRP, analyze their geographical and temporal trends, and elucidate current advancements, gaps, and future directions in DHI clinical research. Methods We conducted a comprehensive analysis of 3,685 registered clinical trials from the WHO ICTRP, spanning the period from January 2005 to December 2022. Using the National institute for Health and Care Excellence (NICE) framework Evidence standards framework for digital health technologies, DHIs were systematically categorized into three levels and eight distinct categories. The analysis focused on these key dimensions: trial objectives, technological trends, geographical distribution, and temporal patterns, providing a robust overview of the evolution and global landscape of DHI clinical research. Results Health promotion (26.6%) and disease treatment (21.3%) are key objectives, with mental health and endocrine disorders as common focuses. Mobile apps have surpassed Short Message Service (SMS) as the dominant technology since 2015, peaking in high-income regions by 2019 and growing steadily in middle-income regions through 2022. Teleconsultation technologies surged post-2019, driven by pandemic demands, while SMS remains vital in low-income countries. Regional disparities persist, with high-income areas conducting over 100 times more trials than low-income ones. Methodological and reporting quality of registered DHI trials needs to be further improved. Conclusions This study highlights global trends in DHI adoption, underscores persistent inequalities in trial distribution, and provides actionable insights for optimizing global digital health strategies. The findings emphasize the need for improved methodological rigor and equitable resource allocation to advance DHI research and implementation worldwide.