In March 2019 I had the opportunity to interview Jennifer Newman, Global Project Leader, Regulatory Affairs/Clinical Operations for Celldex Therapeutics. Newman was once part of the largest implementation of RBM and was able to share insights from her experience. Specifically, she was able to discuss the benefits and challenges of RBM and what companies should be prepared for when adopting the technology. In this video, Newman discusses the biggest lesson she learned from implementing RBM.
Ed Miseta: Implementing a new technology solution is always a challenge, and one of the first challenges you’re going to face is getting internal approval. I have spoken to many readers who have mentioned that challenge. As a clinical operations executive, you might know you need a certain technology.
But that doesn’t make it much easier to get the folks above you to agree with you and to write a check for it. How do we go about doing that, and are there specific metrics or data that you would present to a manager to say, “This is why we need to move forward with the implementation?”
Jennifer Newman: Well, I think the biggest argument is that quality matters, regardless of whether or not it results in large cost savings. In fact, you may be spending more to implement a quality approach upfront. But, at the end of the day, if your data isn’t what it should be, you’re going to pay for that. And you may have to pay for it at a time you don’t want to.
I have heard a lot of cost arguments. In the large study that I worked on, there were some significant cost savings that were promised. Those did not come to fruition. We didn’t shave 50 percent off the cost of monitoring. I think realistically, you can reduce the cost of on-site monitoring using central monitoring and a risk-based approach. But I think it’s more in an order of magnitude of ten percent, and that may or may not be more or less than what you’ve paid to implement it. The argument really is we need to comply with this regulation in the event that we want to submit this data for a claim. It must hold up, and if we don’t have confidence in the quality, then we really can’t stand behind it.
If the organization is driven by time, then I would make that one of your arguments. If you look at your data on a routine basis, and can stay on top of it, then you will be able to lock your database much faster. That is because you will have a system in place that allows you to stay on top of things. Additionally, you no longer have to worry about the things that are not impacting the overall quality of the study.
RBM allows you to deemphasize the pieces that are meaningless to the overall scheme of the study, in favor of understanding and having confidence in your primary endpoints. You will also have greater confidence in the overall quality of the data. That’s one argument for speed. Some organizations are very quality-focused, and I think those are the kinds of organizations where implementing something like this is probably easiest.
The cost argument is probably a bit weaker. But I think one benefit of having a more centralized approach is that you can share that data a little bit faster and have a bit more confidence in what it is, in real time. I think companies, especially small companies, are very interested in getting data as early as possible and as quickly as possible.
Miseta: Other than getting the funding for it, are there other challenges that companies will generally face in implementing this solution?
Newman: Absolutely, and I think it’s interesting. I think that you have just as many challenges on your team as you do trying to convince people to actually implement this and pay for it. What I mean by that is most of us have the background with 100 percent source data verification.
When we suddenly say we’re not going to do things the way we’ve always done them, we’re going to take a totally different approach, what you get is resistance. You may tell everyone that you are going to source verify 100 percent of this and you’re going to source verify maybe 20 percent of the less important points. Still, when you look at your metrics, you find people are still doing 100 percent source verification. It can be very hard for them to let go. I sympathize with that, because if you’re monitoring and you’re going on site, your job is to make sure that this data is what the site says it is.
It can be very hard to say that you are going to look at these fields and not look at other fields. I think you will find that some CRAs will still go out and do 100 percent source data verification, even when it’s not prescribed. It’s just a process. It’s changing hearts and minds. It’s making sure that the value proposition of implementing a change like this is clear to all team members above you and below you. Everybody needs to be on board, and that means everybody needs to champion the idea. Make sure everyone in the organization understands this is not voluntary. It’s mandatory. It is something we all must do.
But then, really make the case for why you are doing it. Start by dipping your toe in the water and allowing everyone in the organization to see the benefits of the change. From there you have a much easier time.