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

Trials@Home Consortium

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish
Article number103520
Number of pages8
JournalDrug Discovery Today
Volume28
Issue number4
Early online date6 Feb 2023
DOIs
Publication statusPublished - Apr 2023

Bibliographical note

Copyright © 2023. Published by Elsevier Ltd.

Keywords

  • decentralised clinical trial
  • direct-to-patient
  • patient-centric
  • remote clinical trial
  • telemedicine
  • virtual clinical trial

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