Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus. Issue 4 (April 2023)

• Record Type: Journal Article
• Authors: Santa-Ana-Tellez, Yared; Lagerwaard, Bart; de Jong, Amos J.; Gardarsdottir, Helga; Grobbee, Diederick E.; Hawkins, Kimberly; Heath, Megan; Zuidgeest, Mira G.P.
• Is Part Of: Drug discovery today. Volume 28:Issue 4(2023)
• Publication Date: 2023-04
• Subjects: decentralised clinical trial -- remote clinical trial -- virtual clinical trial -- telemedicine -- direct-to-patient -- patient-centric; Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2023.103520
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: There is a lack of standardised terminology on decentralised clinical trials (DCTs) A DCT should not be referred to as a remote or virtual clinical trial. DCTs should be understood as an operational model, independent of trial methodology . DCTs ential a trial centred around participants, enhanced by health technologies. Abstract : 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.