ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts?
Getz: Yes, absolutely. And let me position it by just saying that this study really comes at a critical time, right? We’re looking at ICH E6(R3). We know that there had been some work done looking at the landscape of RBQM adoption. And it was primarily looking at the impact that the pandemic might have had on the use of risk-based monitoring in particular, and a few other key areas. But that earlier research had primarily relied on reports from CROs, these were the ACRO landscape studies. So this study, the Tufts CSDD, CluePoints, PwC study really looked at working with a much larger number of companies receiving direct reports from pharma and biotech. We had 125 individual companies respond. And we looked at a much larger collection of RBQM components, 32 in total, that cut across three areas: the planning area, execution, and then documentation and recording. And what we found is that the reported level of use of RBQM components really hovered around roughly half of clinical trials in an organization’s portfolio; less for smaller companies more for larger. So we actually were able to observe some differences by company size. And as we dug deeper, we started to see that there are still areas where there’s resistance that just needs to be addressed. Over time, organizations are having some difficulty changing the culture of the company to move away from a lot of the labor-intensive approaches to use more of a risk-based quality management approach. And some of that has to do with mixed perceptions about the value proposition of RBQM and the ease with which it can be implemented across functional areas. So lots of opportunity to continue to educate and share success stories to try to stimulate broader adoption over time.
