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: What was your biggest lesson learned in implementing RBM? If you could go back and do it all over again, is there anything you would have done differently, knowing what you know now?
Jennifer Newman: You’re always going to be surprised by something. People will go in the direction that you tell them to. If you say it’s important to get first patient in on August 1, people will move mountains to make sure that you get first patient in on August 1. If you tell them it’s important to make sure that there is no patient enrolled in the study that violated inclusion or exclusion criteria, that will be their focus. People will move mountains to accomplish those things they know the organization is paying attention to.
In any management structure, people don’t want to be dinged for the things that they have been told are important. As a leader, you really have the ability to set the tone. You have to set your team in a direction where they’re focusing on what you have all agreed is important. When you do so, that is what you will get.
I do have an anecdote related to this. When I was involved in the large scale system implementation I noted earlier, one of the goals was to try to identify sites that might potentially be at risk for a regulatory inspection. The thinking was that the regulatory bodies were doing using algorithms to try to pull out data flags, and then focus on those sites to make sure that they were inspection ready.
As a result, we spent a lot of time on those high-risk sites. It turns out none of them were inspected. That doesn’t mean it wasn’t a worthwhile exercise. It was. But one of the things that happened during the course of the study was we did have a monitor on site doing very typical source document review.
That monitor had access to patients’ medical information. She’s at one site one day and at another site the next day, working on a different study. Lo and behold, she remembers that she saw the same patient name for another study. Basically, she uncovered that it was a patient who had enrolled themselves into multiple studies at the same time.
For me, that was a huge lesson learned, because there’s no system that you could put in place to capture something like that. As sophisticated as these things can be and as helpful as they can be, again, you still cannot replace the value of people being on site, your CRAs establishing relationships with your investigators and paying attention to the data they are reviewing. You can’t just walk away from those things. You absolutely need to take a holistic approach. That was one of the biggest lessons for me.