Using Site-Validated Technology

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: Then the third initiative on site adoption has been fascinating. The work will continue in 2025 and it has been focused on what would it take for sites to be able to use the technology they've already validated and qualified at their network or location, instead of using sponsor-defined technology for the same solution. I'm not talking about a CTMS for patient scheduling, or all of the regulatory documents. I am talking about things like eConsent. We might think in longer terms about eSource, but when I hear from sites that they have used their own version of eConsent for 800 or more studies, it is hard for me to understand why they would be asked to accept an external eConsent platform by the sponsor. Now, the sponsor wants to ensure the data congruity and integrity is there, and that's really what we're trying to define; what would sites need to be able to show to sponsors to help the sponsors feel that the risk of having multiple solutions has been mitigated? It's really brain bending, because it's truly flipping the whole decision-making framework upside down. That's what we've been working on. We're going to continue some of that work in 2025 including trying to set out what are the questions you would ask sites if you were trying to get their input on the operational plan, and when, also, is there a way to collect high-level insights on the experience from site on using these technologies, perhaps by therapeutic area or region? I don't know the answer to that question. We're just scoping that work, and then we're going to dive in a little different direction into the world of how would HCPs be integrated into clinical research without making them investigators, aligned again, to those guidance documents coming from FDA, both for DCT and for what I call point-of-care trials. First, what do they think about that? Has anyone asked them, “Is this even a viable possibility, given the metrics and the constraints of the healthcare system and how it works?” Then, if it's a yes, what do they need in order for this to work?