Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus

There is increasing interest in clinical trials that use technologies and other innovative operational approaches to organise trial activities around trial participants instead of investigator sites. A range of terms has been introduced to refer to this operational clinical trial model, including virtual, digital, remote, and decentralised clinical trials (DCTs). However, this lack of standardised terminology can cause confusion over what a particular trial model entails and for what purposes it can be used, hampering discussions by stakeholders on its acceptability and suitability. Here, we review the different terms described in the scientific literature, advocate the consistent use of a unified term, 'decentralised clinical trial,' and provide a detailed definition of this term.

Automated summary

There is a growing interest in clinical trials that reorganize trial activities around trial participants using technologies and innovative approaches. However, the lack of standardized terminology for this operational model, known as virtual, digital, remote, and decentralized clinical trials (DCTs), can lead to confusion and hinder discussions on their acceptability and suitability. This article reviews the different terms used in scientific literature, advocates for the consistent use of the term "decentralized clinical trial," and provides a detailed definition of this term.