Overcoming Budget Barriers to Patient-Centric Trial Models

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in clinical trials, emphasizing the need to avoid staff burnout due to inflexible SOPs and budget constraints. She highlighted strategies such as in-home visits and community outreach as essential for reducing recruitment delays and improving trial diversity. Potts also touched on budgetary issues as a major barrier to patient-centric models, with a call for better dialogue and innovative solutions. She stressed the importance of community engagement, temporary clinic sites, and collaborative efforts among key stakeholders to better serve diverse populations in clinical trials.

ACT: What are the biggest operational barriers preventing sites from adopting more patient-centric trial delivery models?

Potts: Truthfully, I think it's the way that the budgets are put together. I'm not trying to say that sites and site staff are all good, and trial sponsors and trial CROs are all bad. It's not as easy as that. That's not what I'm saying here, but I think there is more dialog that could certainly help a site to feel that they can put forward a slightly more unusual solution, like community engagement. That tends to be one of the things that we hear gets knocked out of a budget suggestion and a first iteration of a budget, which is a real shame for the reasons that we've just been talking about. I think that trials are expensive. Trial sponsors, trial CROs, are still on the receiving end of opening sites where there is no recruitment despite best intentions, so we have a bit of an impasse with everyone making really good arguments as to why they can't think outside of the box, but it's that old adage, if you always do what you've always done, you'll always get what you've always got, so we do have to think more laterally and maybe just give it a try. I'm not suggesting throw millions at it when we don't know if something has been tested and has been successful, but the dialog needs to be had, and the discussion should always remain on the table.