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Abstract

The evolution of clinical trials has been significantly accelerated by the integration of digital technologies, giving rise to Decentralized Clinical Trials (DCTs). These digitally enabled trials offer a modern alternative to traditional site based research by incorporating tools like telemedicine, wearable devices, mobile health applications, and remote monitoring systems. DCTs enhance patient access, engagement, and data collection, making research more inclusive and representative, especially for marginalized populations. The COVID-19 pandemic catalyzed the adoption of virtual healthcare, highlighting the potential of DCTs in ensuring trial continuity under challenging circumstances. Digital health technologies (DHTs) provide continuous, real world data that improve the precision of disease monitoring and outcome measurement. Innovations such as the digital twin model and blockchain based platforms further strengthen data integrity, transparency and regulatory compliance. Artificial Intelligence (AI) and Machine Learning (ML) optimize trial designs and recruitment, while telemedicine and mobile apps enhance convenience and adherence. Despite their many advantages including cost efficiency, scalability and improved data quality DCTs face limitations such as technological disparities, data privacy concerns and operational complexities. As regulatory frameworks evolve to support these advancements, DCTs are poised to become the future of clinical research, transforming the way treatments are developed, validated and delivered to diverse patient populations.

Keywords

Decentralized Clinical Trials Blockchain based platforms Artificial Intelligence Machine Learning cost efficiency scalability and technological disparities

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