Keeping Clinical Trial Sites Informed

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 initiatives DTRA is currently working on? What excites you the most?

Myles: We have a lot of things happening, so we're just completing some work from 2024 on three big topics around site adoption and a fourth around digital health technologies (DHTs) and the concerns about using DHTs from site and sponsor perspectives. I'll start with the site adoption. We've had three initiatives this year. Some will continue, by the way. One was really trying to understand how we might ask sites for their input around the use of DCTs (decentralized clinical trials) as the protocol was developed, that's evolved a little bit, and now we're thinking more, how do you ask for input around the operational planning of the study, as opposed to the scientific endpoints? That work will continue this coming year, in 2025 and what's really exciting to me about that work is that it's really a set of collaborations across primarily TransCelerate and DTRA, but with connections to SCRS and ACRP. The reason I call that out is because we're expanding the ecosystem, so you really do get that perspective from all the different stakeholders.

The second initiative, and this is the last meeting I was in, actually. We just wrapped up the work to try to codify what do sites need to understand when they're being asked to use these methods in trials, and it is not in the form of training. We actually worked with a cross -stakeholder team and came up with the question set that needs to be asked both at feasibility to the sponsors and at the investigator meeting or site initiation meeting by the sites with clarity on not only what's going to happen, but who's actually going to do the work. I'll give you an example, and it's interesting that this is not clear, but a lot of times, some of that tech friction that you mentioned earlier is related to the fact that the site becomes, or feels they become the tech support desk, and because that's a little bit in the weeds, it doesn't always get clarified anywhere in the study operations documents. The question set that we put together, which is across nine capabilities is: what do you need to know? When do you need to know it? Who needs to take action on it? This is so that the sites can feel like they're better informed in what they are agreeing to use, and more clear on the expectations of their roles in actually using these methods.

One of the big surprises for me this year was that when we did interviews with sites from across the world, different sorts of sites, academic sites, standalone sites, sites built for virtual visits, and meta sites, a lot of them reported that they actually didn't find out that DCT methods were being used until the investigator meeting or the site initiation meeting. That is probably in part related to the fact that until the final guidance came out this September, it wasn't clearly stated that those DCT elements needed to be included in the protocol. I was guilty of this myself when I did this back in big pharma, I would offer those methods, but not codify them in the protocol, so if you were not asking the questions that we put in that initiative work stream, it might be clear to the sponsor and not yet clear to the site.