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 whether or not RBM might be a fit for your company, and dispels some of the myths about RBM.
Ed Miseta: You helped implement RBM in a large-scale study. The members of our peer group work for small- to mid-sized companies. Some may wonder if the size of their pipeline or the cost of implementation can make certain technologies prohibitive. Do you have any advice for those folks? Is this still something they should be looking into and incorporating, regardless of the size of their company or their study?
Jennifer Newman: I have seen different RMB systems. Smaller companies may not have RBM implemented in a formal sense. However, I think of RBM and quality management as more as a process.
RBM vendors will sell you on all the advantages of their system. If it’s not for you, it’s not for you. If it’s something that you’re not at the right scale to implement, then it won’t make sense. Not every company will need to implement a formal risk-based monitoring approach.
Companies can still do 100 percent SDV in a first-in-human study, and I think that’s appropriate. RBM becomes more appropriate when you start to grow and get into later Phase 2 and large Phase 3 studies. That’s when it begins to make more sense. But every company should still implement a risk quality management system.
In other words, go through the exercise of looking at your protocol, looking at the data, and then having processes set up for the courses of study that you are periodically checking in, and you have a few indicators, and now manage it that way.
Miseta: A few years ago when I first heard people start talking about RBM, we heard a lot of horror stories. People were predicting that CROs won’t go along with RBM, since they make so much money off the billings. I heard others say a lot of CRAs were going to be out of a job as a result of not verifying everything 100 percent. None of that seems to have happened.
Newman: It was the same thing with data entry. When I started in industry we had a room full of people just doing data entry, and they said, “Well, if we do electronic data capture, all those jobs go away.” They didn’t. This is just an evolution.
Pharmaceutical and biotech companies are notoriously slow to adopt new technologies. I read that Big Oil and Big Pharma are two industries that have not really improved their efficiency, despite having access to wonderful, new technologies. Part of that is because, although we have these new systems in place, we don’t embrace them very well. But trials have also gotten more complex, and that has eroded some of the technology gains that we would have had.