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What are decentralised clinical trials?

Clinical trials are essential to prove the safety and efficacy of new medicines. They remain challenging to deliver due to low participation rates. Decentralised Clinical Trial (DCTs) approaches hold the potential to address some of these challenges.

Decentralised clinical trials are trials in which activities are designed to take place at, or in the vicinity of, the participant’s home, rather than at a traditional clinical site. This approach can make use of electronic health technologies and other innovative operational approaches to facilitate data collection.

Should you want to know more, watch this video:

Types of decentralised approaches

In a fully decentralised clinical trial, participants never physically visit a site, although in most trials they still have contact with the investigational team remotely. However, many clinical trials merely involve DCT elements without being fully decentralised. There are many decentralised elements that can be introduced in a trial, some of them figured below:

Further reading

Publications

Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019-2020? A cross-sectional study in ClinicalTrials.gov

de Jong, et al
BMJ Open
2022

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

Santa-Ana-Tellez, et al
Drug Discovery Today
2023

Other resources

Podcast

The Future of Medical Research

A video from The Lancet featuring Trials@Home
September 27, 2023

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