The value of decentralized clinical trials: Inclusion, accessibility, and innovation

Abstract

In this Review, we explore the transformative potential of decentralized clinical trials (DCTs) in addressing the limitations of traditional randomized controlled trials (RCTs). We highlight the merits of DCTs fostering greater inclusivity, efficiency, and adaptability. We emphasize the challenges of RCTs, including limited participant diversity and logistical barriers, geographical constraints, and mistrust in research institutions, showing how DCTs are preferred in addressing these challenges by utilizing remote digital technologies and community providers to enable broader, more inclusive participation. Furthermore, we underscore the potential of DCTs for democratizing clinical research. We also stress the importance of addressing unresolved challenges, including data security and privacy, remote patient monitoring, and regulatory variations. Research is needed to devise standardized protocols to streamline DCT processes, explore its long-term impacts on patient outcomes, and overcome challenges through equitable stakeholder engagement.