TY - JOUR
T1 - Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus
AU - Santa-Ana-Tellez, Yared
AU - Lagerwaard, Bart
AU - de Jong, Amos J.
AU - Gardarsdottir, Helga
AU - Grobbee, Diederick E.
AU - Hawkins, Kimberly
AU - Heath, Megan
AU - Zuidgeest, Mira G.P.
N1 - Funding Information:
The Trials@Home project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement n° 831458. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and EFPIA. The Innovative Medicines Initiative website can be accessed through the following link: www.imi.europa.eu . The research leading to these results was conducted as part of the Trials@Home consortium. This paper only reflects the personal views of the stated authors. Patients or the public were not involved in the design, or conduct, or reporting of this manuscript.
Publisher Copyright:
© 2023 The Authors
PY - 2023/4
Y1 - 2023/4
N2 - 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.
AB - 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.
KW - decentralised clinical trial
KW - direct-to-patient
KW - patient-centric
KW - remote clinical trial
KW - telemedicine
KW - virtual clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85150069840&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2023.103520
DO - 10.1016/j.drudis.2023.103520
M3 - Review article
C2 - 36754144
AN - SCOPUS:85150069840
SN - 1359-6446
VL - 28
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 4
M1 - 103520
ER -