Industry Perceptions of Decentralized Clinical Trials

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized clinical trials (DCTs) including misconceptions and the rapid adoption of DCT elements. Myles also highlighted DTRA's initiatives on site adoption, operational planning, and the integration of digital health technologies.

ACT: What are some trends and challenges you’re currently seeing with decentralized clinical trials (DCTs)?

Myles: I would say that maybe people are a little bit allergic to the term DCT, which doesn't mean they're not using DCT elements. What I mean by that is there are a lot of people who hear DCT and react just to the acronym, and many of them are potentially thinking DCT means fully remote, which, as we know, it doesn't. When they hear DCT, it conjures up these concepts of site-less trials and fully virtual and nobody ever sees a doctor, and we know now that is not the case for the vast majority of trials where DCT elements are used. It's even reflective of how the FDA guidance on DCTs changed from draft to final form. The terminology DCT is an allergen, but the adoption is actually going pretty quickly. I would say, realistically, there's still challenges implementing DCT elements across different regions of the world, just because they need to look like the actual processes are a little bit different in different places, but I wouldn't say that it's because there's a technology gap, or even a will to use gap in any one region.