A new paradigm of clinical research: decentralized clinical trials


Medical Manager, Prineos Srl ,Italy

Site-based clinical trials have been the gold standard of clinical research: study participants are recruited and enrolled in a healthcare setting, and are required to attend study sites on a regular basis for in-person visits with the study doctor.


Nonetheless, this approach has been shown to be costly, slow, and often inefficient, as well as burdensome for participants and caregivers due to travel and other logistical demands(1–3). Indeed, one major cause of trial failure is the inability to enrol and retain a sufficient number of participants (3).


Trial decentralization is gaining momentum as one way to improve clinical trials. Decentralized clinical trials (DCTs) are aimed at making studies centred around participants’ needs and preferences, leveraging evolving technologies/services to move study activities to participants’ homes or local surroundings(4–6).


This article illustrates the key features and advantages of DCTs, as well as the main challenges to be tackled to foster the successful implementation of this novel paradigm of clinical research.