From site-centered to patient-centered: Promises and challenges of decentralized clinical trials in oncology

Decentralized clinical trials (DCTs) are an innovative model of clinical trials in which some or all activities take place at, or near, participants' homes rather than at traditional clinical sites. DCTs represent a shift from a traditional site-centered approach to a more patient-centered one, leveraging digital tools, home-based services, and local healthcare networks. While DCTs can broaden participation and improve equity, they remain underutilized worldwide. The COVID-19 pandemic demonstrated their practicality, but also highlighted challenges such as uneven regulations, logistical complexity, digital literacy gaps, and data-privacy concerns. The objective of this narrative review is to critically evaluate the implementation of DCTs in oncology, examining their potential benefits and limitations and how decentralization may reshape key trial activities, including recruitment, informed consent, investigational drug delivery, monitoring, and data collection. We further assess the organizational, regulatory, technological, and equity-related conditions required for sustainable implementation and discuss the role of hybrid models. Rather than representing a universal alternative to conventional trials, DCTs should be viewed as a flexible model whose value depends on the clinical context, trial design, patient population, and healthcare infrastructure.