SCOPE Summit 2025: Implementing Decentralized Elements

ACT: What are some barriers that stakeholders struggle to overcome when they want to implement more DCT approaches?

Tenaerts: What I think, and why I think it's important to support groups and consortia that collect data is that we've had a lot of hype and hopes for using technology and modern clinical trial elements, but we don't have a lot of evidence of what it actually does, so this effort really gets us at that evidence where we start learning, how does it change protocol, performance, what should we use, where? Because as we get more data, we also know really well what the trials are that we're studying those elements, so we'll know what it's cardiology, in oncology, exactly what modules they use and exactly what outcomes they have so that when we start getting more data, I think people will know that it can get them what they want, and that I think there's hesitancy around is it really going to get me what I want? I think this is one of the elements. The other barriers that people might have had was regulatory acceptance, but I think in the last couple of years, we've gotten a lot of guidances indicating that, yes, the regulators are in favor of this, if you do it right. I think we've also gotten to better workflows and better products over time.

ACT: What are some other projects or initiatives the PACT Consortium is working on that excite you most?

Tenaerts: What we've learned with PACT is that we had an initial set of metrics that we were calculating, and what we're finding is now that we're getting evidence of some of those elements, people are drilling down on those elements, so there's another layer of metrics that we will be exploring. I think that's the interesting part, is this is really like an onion, like in the first year, we started asking about the more obvious data elements of protocol performance and reaching the right populations and now we're getting deeper and deeper and it's really going to be fascinating to see what we're going to learn about what using technology in clinical trials does for us, just as much as how we use technology in the real world, right?