Increasing Comfortability With Adopting Risk-Based Approaches

ACT: How do you think industry can increase the level of comfortability with adopting risk-based approaches?

Getz: I'll start, but I know Steve, you have so much direct interaction. From the survey, what we saw were a couple of really key suggestions. One was that we need to do a better job of publicizing internally and also sharing more broadly, some of the real success stories that have come from real RBQM (risk-based quality management) implementations, and use cases. In some organizations, the impact is known by a core group, but it's not broadly shared, how often it's not receiving visibility with senior management, and then making it into a lot of the functions that are more peripheral to a given activity. So that's part of it, being able to really publicize and share those learnings is key. The other is for some of the smaller companies, we heard that they often don't take the time to build a real coherent change management strategy. So, every time they implement a set of components, it has a novel feeling to it, it's not becoming a standardized practice. They're not providing the training, they're not necessarily providing the support and the infrastructure to ease every team into more mainstream usage.

Young: Yeah, absolutely. There's certainly various reasons for continued non-adoption or resistance. And Ken, I think you've hit on some of the key ones and I'll just support that. It's interesting, I referred to the EDC (electronic data capture) transition years ago, there was various reasons for that taking 15 years, right? It was a paradigm shift, it was disruptive to a lot of people's jobs, or at least perceived to be because it was changing roles, it was a different way of doing things. But to be honest, what probably was the final solution, in that case, that really tipped it to business as usual, was a technical one, it was availability of broadband internet globally. So probably around 2005 or so you started to see it really take off, right?

In this case, with RBQM, we don't have that same, in my view, technical limitation, right? There's technology out there. You say, “Oh, well, the supporting technology can get better, but there's no fundamental infrastructure problem.” It really is more about change management. And part of it has been because it doesn't touch just one part of the organization, it touches everybody, right? This is a cultural shift for the entire industry, for the entire organization. Wherever you are, whatever stage of study design or planning or execution you're in, the mindset changes to risk-based, so it's affecting everyone. That raises the bar even a little further, right. And that's what we saw, the lack of cross functional awareness. So as Ken said, the education is a big part of it, and convincing people with actual success stories, and we were already seeing that, that is making a big dent where we have been able to educate people.

It was like eight years ago, we published that analysis on source data verifications impact on data quality, and showed quantitatively with a very rigorous analysis that it has very little meaningful impact on the overall quality of clinical data. That piece of evidence itself, I know, has been used across the industry in so many organizations as a compelling way to convince colleagues that the old approach is something we don't have to hold on to, we can move forward with RBQM. So one of the things that we're trying to do is continue to do more analyses that reveal and expose the value of this RBQM approach, based on actual experience. I was just at a community of users meeting, a user group meeting last week for my organization with a lot of different pharma companies and implementing RBQM and we had a really good discussion about the library. We have case studies that we're all collectively building up. And actually, we're encouraging sharing across companies so that people can use them with their organizations. And there was a common excitement about, “Yeah, this is exactly what we need.” We need these type of success stories and case studies to convince people.

Getz: So one other thing I'll add, Andy, and I know I'm going to get a reaction from Steve, this is a two part thought as well. And that is that often, we choose to name a potentially transformative innovation in a way that actually elevates the risk aversion inherent in our industry by calling it risk-based monitoring, risk-based quality management, there are people who initially had sort of a visceral negative reaction just to the name itself, not really understanding what it was all about. During the pandemic, we also saw great increased use of RBQM components out of necessity. And just like we did with all the virtual and remote solutions that I know you've covered. And with the pandemic, in the wake of the pandemic, you started to see within organizations, more of that risk aversion, the necessity of using these types of approaches weighing, and I think RBQM sort of fell into that group a little bit as well, companies that had had exposure, the commitment wasn't necessarily there to continue without the necessity to use it. And that's what we're trying to address and make it more sustainable with what Steve was describing, that education, that real visibility into these use cases.