Implementation status and consideration for the globalisation of decentralised clinical trials: a cross-sectional analysis of clinical trial databases.

Abstract

To comprehensively elucidate the current landscape of decentralised clinical trials (DCTs) and identify notable aspects that can facilitate DCT implementation. Cross-sectional analysis. Data were extracted using selected DCT-specific search terms on 4 June 2022, from the ClinicalTrials.gov database and on 2 September 2022, from the Japan Registry of Clinical Trials and Japic Clinical Trials Information. We characterised trials based on the four components of DCT: telemedicine, home healthcare, direct-to-patient and the Internet of Healthcare Things (IoHTs)/Internet of Medical Things. Data obtained from ClinicalTrials.gov indicated that the number of DCTs has increased annually and exponentially since 2020. DCTs for cardiovascular diseases are the most common, and the digital platform for patient monitoring is used the most in DCTs. The Japanese databases also showed that DCTs have increased in recent years, and the data on disease areas and IoHTs were similar to those obtained from the ClinicalTrials.gov database, except for the number of studies. Approximately 9.2% of DCTs were conducted across multiple regions, whereas over 80% were conducted within a single country. This study revealed the comprehensive trend of DCTs in the USA and Japan and helped identify widely implemented DCT components and the therapeutic areas in which they are implemented. International consensus guidelines for DCTs are necessary to promote multiregional clinical trials with DCT components.