Anyone involved in clinical research will have come across the phrase ‘decentralized trials’ – or DCTs. Recently, the FDA issued its draft guidance on its approach to regulating DCTs, which it defines as “..a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.”

Which includes what we in the industry might call ‘hybrid trials’ – where some activities occur at a research site, and some occur elsewhere, such as in a patient’s home.

Since the Covid pandemic, there have been a lot of solutions developed for helping to deliver DCTs – the majority of them based on tech or digital applications. And all of them in some way trying to replace the traditional method of doing things with a new way that is supposed to make things easier for the trial participant. I’ll look at some of these methods in the next vid.