Key Takeaways From the 2024 DTRA Annual Meeting

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: The 2024 DTRA Annual Meeting was just a few weeks ago. What are some of your key takeaways from the event?

Myles: Wow, so many of them. First, we had a lot of people from different regulatory divisions and agencies, and in some ways, maybe it confirmed my bias, but I feel like the regulators are on board and ready, like they couldn't really send more clear signals. In fact, I think one of the stunning moments for me, like in a really positive way, was that we had a session that I was moderating. I called it lessons from the field. We had the sponsor, the investigator, the FDA reviewer and a member of BIMO the inspectorate, all talking about what they see, what they imagine, what's been hard, what's been surprisingly easy. When the inspector says, “Don't be afraid, you need to try these things, we want patients to have access. We're going to ask more questions because we're learning along with you, but we're not going to ask different questions.” That's a call to action for me, those inspectors are learning and curious, but it isn't because they don't want this to be something that's accessible to patients, so that was one big highlight.

I would say the other theme that came out loud and clear is that the people who came to our meeting are not there because they're proselytizers of technology, for the sake of technology, there's a very shared mission here around equity and access for patients to trials as healthcare options, and that's global. Our Japanese participants, who were from oncology and tech vendors and academia, actually said we are not just DCT (decentralized clinical trial) ready, we are DCT ready with a bullet train because they've realized that their geographic distribution of patients and the age demographics of their population actually make it imperative to offer DCT options. Now, I hear a lot of people in the US thinking that older population, rural, and widely distributed is a bad set of demographics for DCTs, Japan is feeling exactly the opposite, so access almost a moral imperative, not for technology, but to actually improve patient treatment options.

Then, I'm just super impressed by what is happening as people do dig in and go beyond their first experience with DCT, and how we see these best practices and learnings coming up, especially in relationships that are sustained between tech providers and sponsors. What I mean by that is the first time you do anything, you learn a lot, then you get to apply those lessons in your next cycle. If you're on cycle five or six or 15, you're starting to get a pretty good machine running now and we were hearing some really great examples about that from our members at the annual meeting. I came away from the meeting feeling enthusiastic and optimistic because it gave me evidence that this is not just a hype cycle, it's now getting integrated. There will be a point in time where we don't talk about DCT, we just talk about clinical trials.