Balance Capital And Labor For Successful RBM Implementation
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 balancing technology and labor for a successful RBM implementation and how to incorporate RBM into your protocol design.
Ed Miseta: For any task that you perform, you can use capital, labor, or some combination of the two. With RBM, it seems like you could use a lot of technology or you can hire experienced people to do the monitoring. Like anything else, it seems like you really need a good mix of both. How do you properly balance the two?
Jennifer Newman: Well, I think you know your teams. I think smaller companies tend to hire experienced people in general. If you are a smaller company, you also know what your team is capable of and what you can rely on them for.
If you think about it, we’ve been taking a people approach for many years and are now just now starting to rely on technology. Keep in mind that this is not a cut and dry change. We are still giving very good, valuable input to those systems. If the input is good, I feel you have a much more reliable system. The approach you take should really be a balance. Technology is great, but you do need to have people who truly know what they’re doing and know what to look for.
Miseta: What insights do you have about protocol design and how to include RBM in the concept stage? I guess if you’re starting a trial, is this something you want to think about very early on in the process, and are there ways to incorporate it into your protocol design?
Newman: Yes, absolutely. I started out by talking about terminology, and I think quality by design is very important. There is some resistance in organizations to adopting it, because it slows things down. It does so for a reason. You want to make sure that your teams are thinking about protocol and how we’re going to make sure that our systems are appropriate.
There is another thing that should be mentioned: If you are collecting information that you don’t need to, it may seem harmless. But any time you do that, you’re directing resources away from things that matter. Protocol design and effective monitoring plans are the transition from quality by design to risk based monitoring. Specify what your monitoring plan is. If your monitoring plan is just driven by a system, it’s driven by key risk indicators that you’ve proactively defined at the beginning of the study. Then you have set up your risk based monitoring right at the beginning.
From there, it should be pretty much on autopilot. You’re going to be checking in and making sure that things are going according to plan. Also don’t forget that no system is going to be able to effectively capture every risk. There’s going to be things that come out of the blue and surprise you.
I’m sure we all have war stories, where things were unexpected. I think it ties together linearly. You set out to have a quality protocol, quality data collection tools, thoughtful plans to capture and monitor and report, and then you follow up with a very disciplined review of your data on an ongoing basis, and you tweak as you need to.