Understanding the True Meaning of Risk in Clinical Trial Operations

In a recent video interview with Applied Clinical Trials, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in the trial master file (TMF) space, highlighting outdated regulations such as ICH E6(R3). When it comes to innovation and compliance in the space, he stressed the importance of a risk-based approach, focusing on critical records and leveraging artificial intelligence for big data analysis. Moving forward, Jones believes the TMF community's collaborative nature can be viewed as a strength in navigating regulatory changes and technological advancements.

ACT: What should leaders in the TMF space be focused on the most in navigating the increased demand for quality and compliance?

Jones: I mentioned, not only have we got these new regulations, but things are changing at a rate that we've never seen before, we can't keep up with. There was a time back in the 2010s where it felt like there was new things happening all the time with, again, bringing in a real foundational level smartphones and tablets and suddenly, internet everywhere, but we're even past that now, it's moving even faster. I think the thing is, if you look at things like ICH E8(R1) that was released the other year, that was almost like a foundation for ICH E6(R3), and it really talked about quality by design. It really talked about thinking about the holistic and bigger picture. They talk in there that if you're thinking about going to certain countries, don't wait until further on down the line, just incorporate those countries into the trials you're doing. That means that trials are going to become more complicated. Complication brings cost, and fast and complicated bring risk. There's no getting around that. Risk is a big, big thing, but again, ICH E8(R1) really built in the idea of quality by design and risk being a big part of that. ICH E6(R3) also talks a lot about risk. I think the thing that we should be focusing on from a leadership point of view, is really understanding that word, risk-based has been a buzzword for as long as I've been around in the scene. We've talked about risk-based, we've talked about these different approaches, but I think it's time for us to really think what that means. Risk inherently means the potential of something bad happening. It's our job to understand that and do what we can to minimize it. In the past, terms like fit-for-purpose, good enough, they're almost dirty words. They were sins. “Good enough isn't enough.” Actually, it is now, that is enough.