Beyond the Growth: A Registry-Based Analysis of Global Imbalances in Artificial Intelligence Clinical Trials.

: While the integration of artificial intelligence (AI) into clinical research is rapidly accelerating, a comprehensive analysis of the global AI clinical trial landscape has been limited. This study presents the first systematic characterization of AI-related clinical trials registered in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). It aims to map global trends, identify patterns of concentration, and analyze the structure of international collaboration. : A search of the WHO ICTRP was conducted on 20 June 2025. Following a two-stage screening process, the dataset was analyzed for temporal trends, geographic distribution, disease and technology categories, and international collaboration patterns using descriptive statistics and network analysis. : We identified 596 AI clinical trials across 62 countries, with registrations growing exponentially since 2020. The landscape is defined by extreme geographic concentration, with China accounting for the largest share of trial participations (35.6%), followed by the USA (8.5%). Research is thematically concentrated in Gastroenterology (22.8%) and Oncology (20.1%), with Diagnostic Support (45.6%) being the most common technology application. Formal international collaboration is critically low, with only 8.7% of trials involving multiple countries, revealing a fragmented collaboration landscape. : The global AI clinical trial landscape is characterized by rapid but deeply imbalanced growth. This concentration and minimal international collaboration undermine global health equity and the generalizability of AI technologies. Our findings underscore the urgent need for a fundamental shift toward more inclusive, transparent, and collaborative research models to ensure the benefits of AI are realized equitably for all of humanity.