The Reality of Operational Flexibility for Trial Sites

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 does operational flexibility really look like for sites today? How can it be implemented without adding to staff burnout?

Potts: I think the key point there is the staff burnout. I think everyone likes to genuinely believe that operational flexibility exists, and I'm just not sure that that is the true lived experience of site staff. I think that everyone wants to do a good job, everyone wants to be able to offer solutions that perhaps are nonstandard, or seen as nonstandard, but SOPs, budgetary constraints, time constraints, availability of staff, availability of patients, all of those things can—more often than not—count against this idea of having the flexibility. I think that it does run the risk of leading to staff burnout as a result of that, unfortunately. It's a great concept, and I think everyone should still continue to try to strive for it, but I think the reality is a little bit different to that.