In November, Charlotte, N.C.-based Advocate Health launched a systemwide clinical trial network. The Advocate Health National Center for Clinical Trials aims to make clinical research part of routine care within the health system’s 69 hospitals, more than 1,000 care sites and nearly 6 million patients spanning across six states.
Jamy Ard, MD, chief science officer at Advocate Health, and director of the Clinical and Translational Science Institute at Winston-Salem, N.C.-based Wake Forest University, was tapped to serve as clinical lead for the network.
He spoke to Becker’s about the infrastructure, leadership commitment and operational changes necessary to integrating clinical trials as a systemwide priority.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: What drove Advocate Health to adopt embedding clinical trials as a systemwide priority? Why now?
Dr. Jamy Ard: For Advocate Health, the concept of integrating clinical trials as a model of care really came out of the Rewire 2030 strategy. All of the components that we’re building as a part of that strategy — from care navigation, care model engineering, our data strategy and our platform for democratizing access to data, along with the integration of the academic core of Wake Forest School of Medicine into the health system — really came together nicely to really enable us to be able to do clinical trials at scale.
It hasn’t been a choice of whether we do clinical trials or not, because we were already doing clinical trials, but it was done in a given region with a given investigator across the health system. What we’ve been able to realize is that we now have the infrastructure, including things like one Institutional Review Board for the entire health system, two instances of Epic across all of our providers and locations, and a unified cloud data platform. All of that infrastructure really enables us to think about clinical trials as a model of care, which aligns nicely with our mission for driving improvements in care for all.
We also see the opportunity of our scale plus the academic integration to really drive meaningful impact to changing this idea that it takes a long time for therapeutics to advance and come to market. We believe we can change that 17-year time frame that it takes for a product to go from discovery to being in the hands of a patient.
Q: From a clinical operations perspective, what were the first capabilities you knew needed to be in place to make a national, integrated clinical trials infrastructure viable?
JA: The biggest operational element that we added was a focus on study startup. This is a chronic pain point for anyone who understands the way clinical trials work. It can be slow, it can be laborious and it can mean a missed opportunity to get patients engaged in a trial.
We put a lot of emphasis on creating efficient pathways for us to identify trial opportunities, work with sponsors to get those trial opportunities into the sites, get those sites activated and help investigators move quickly to make the trials available to patients.
That is the key focus for the early operation, driving a steady startup process and having people who understand that process who can, in a concierge-type way, guide the investigative teams and the study teams through the process to get trials started. From a sponsor, pharma or device medtech perspective, it streamlines that process for them. They have one point of contact, they know who to go to for answers to questions. From an operational standpoint, that was the primary area we knew was important to get right.
Our near-term goal is to be able to realize the opportunity to say, if you’re a patient in Wisconsin but we have a clinical trial that you might meet the criteria for in Charlotte, you should be able to participate at a site near you. We’re not quite at that point, but the intent is to build our network of sites so that we have coordination across those networks and can provide a similar set of opportunities for trial participation no matter where you are in the Advocate enterprise.
We have what we would call established sites and then we have a number of sites that we will activate to bring online as new sites and add new capacity. Then we will start to stitch those together into networks, and those networks of sites will then allow us to provide access to clinical trials across the system that are coordinated and connected to multiple sites.
Q: How are you measuring success in regard to trial equity and inclusion? What does that tracking process look like in practice?
JA: Our size and scale is a unique opportunity and advantage, particularly when it’s appropriately enabled through the academic core, through the infrastructure build and through the commitments from leadership. We have a really tremendous opportunity to reach into populations that don’t typically get involved in clinical trials.
Only 5% of the population engages in a clinical trial, probably less even know about clinical trial opportunities. It is so important for us to bring treatments and therapeutic strategies — that we know are effective — to all of our patients. We serve a diverse community across rural and urban regions.
We serve all different races, ethnicities, males, females, children and older adults. It’s important for us to know the treatments we are recommending work for the people that we serve. If you have clinical trials that don’t include people who are representative of the patient population you’re treating, then you have to make some jumps. None of us as clinicians want to have to extrapolate data from one group to another and assume that it might work.
One of the basic ways that we’re going to measure success is by looking at the inclusion in the trials that we recruit and saying, does this match the patient population that we have?
If we see that we’re recruiting for, let’s say, a trial that deals with heart failure, and we know that 30% of our patients come from under-resourced communities, but the patient population that we have in a clinical trial only has 5% of those patients, that means that we haven’t done our job. We have to hold ourselves accountable to delivering on that promise.
Q: What lessons or practical takeaways would you share with other health systems considering similar moves to decentralize and democratize research?
JA: There has to be commitment throughout the organization to building this model. If you are going to commit to clinical trials as a model of care, it means that you’re saying you value clinical trials just as much as you do any other type of care, whether it’s inpatient or outpatient care, intensive procedures or diagnostics. And in saying that, you will do what is necessary to engage all members of the team in that clinical trial.
It is a significant commitment because it means that you have to think about compensation models, you have to think about space allocation and usage, you have to think about how to integrate a number of systems that may not normally talk to each other, and you have to think about data and using data for operations versus research.
We’ve been fortunate that our top-down leadership throughout the organization has been fully on board and committed. Not just in terms of the investment to stand this up, but also in terms of creating the lanes and the opportunities for the right policies, the right set of integrations, and building the right teams that allow us to effectively do this work.
If this were not the case, this would be doomed to fail. A full commitment to integration cannot be underestimated.
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