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: From a decentralized clinical trial (DCT) perspective, what are some best practices to ensure that stakeholders don’t feel overwhelmed by technology?
Myles: I actually think that the sponsors are becoming more familiar with the technology, which is not to say that every person is familiar, and that’s, I think, one of the biggest challenges of the change curve of adoption in industry. We have been using some of these elements in trials now for nearly two decades, and yet it may be the first time that the individual study team member is using them, either at the site or at the sponsor study team, so there’s always a little bit of friction the first time you use things. Yet, what we’re hearing from some of those sponsors is now these elements are routinely included in 80% of their global trials, which does not mean every patient is going to experience every possible DCT element, or every country or site will adopt them all, but they’re designing the protocols so that these elements are included from the start. I think that that overwhelming feeling in part, might be related to how many sites and many study team members—not the innovation group—but the study team members had to adopt these methods, kind of on the fly during COVID and if that was your first experience, it did feel really overwhelming.