Ken Getz of Tufts CSDD and Steve Young of CluePoints Discuss Stand Out Results from Recent RBQM Study


In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints highlight what stood out to them from the results of a recent study on RBQM adoption.

ACT: What do you make of the results of the study? Was there anything that stood out?

Young: Oh, sure. So I mean, as Ken said, bottom line, it showed very clearly that there's still a ways to go. I mean, we've been at this as an industry for over 10 years now, I would say probably, depending on when you want to start the clock, you could say 2011 when the FDA and EMA posted guidances encouraging a risk-based approach. That's 13 years ago, people were talking about it even earlier than that in various forms. So we've been at it a while. This industry is always conservative in terms of making change, right? Changing to new ways of doing things. I mean, we can remember with EDC (electronic data capture) for those of us who have been around long enough, there was probably from early pilots of EDC in the early 1990s, until it really hit an inflection point, was about 15 years. We're rapidly approaching that now. Now, the good news is from this study, we're not fully there yet, we are over 50% in terms of overall adoption, which isn't bad. And in my view, it kind of reinforces that not only do we have a ways to go yet for full adoption and making it business as usual. But we, in my view, we definitely have hit an inflection point. So I think when we run this survey, again, in a year or two, I think, or a couple of years, we'll see that. I fully expect it's going to be significantly higher.

Getz: And, Andy, I'll just add to what Steve has said that there was a lot of variation observed as well, there are some companies that are much farther along. And others, typically the smaller companies that seem to be behind are sort of the laggards. So I agree it really presented a very promising picture, we're closing in on around 60% of trials on average. But there's clearly places where we can do even more to help stimulate and drive adoption.

Young: Yeah, and I think I'll add that one of the areas in particular that stood out was smaller organizations, I think we saw that there was clearly less adoption in organizations that are running 25 trials or less per year, than the larger organizations. So that's one area where they need to catch up. And of course, there's likely various reasons for that. Ken mentioned some of them already, but often their priorities tend to be, or can be significantly different, that they might be relying on their outsourcing partners to basically run their trials. And making RBQM (risk-based quality managment) a priority isn't necessarily on the top of their radar right now. But that also gets to lack of awareness, or perception, which is also some of the data we collected from the survey that lack of adaption is still being driven in large part by lack of awareness.

Getz: One of the things we saw Andy was that you can try to break the value proposition into a couple of key areas: do you expect to see RBQM contribute to improvements in quality for example, and the expectation and experience to date has been relatively high. But when you ask, do you expect it to lower cost and drive efficiency, you start to see more variation depending on the functional area where the respondent sits. Often some of the operating areas; clinical operations might be more risk averse to try something like this on legacy activity, for example. So it's when you start to get into the nuances of the perceived benefits where you start to see a few pockets or places where there's more of a mixed perception at this time.

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