From your perspective as a former healthcare executive, what is the attitude around clinical research?
It’s just not on the top list of strategic priorities for executives in community hospitals. It’s not that executives don’t think clinical trials are valuable, but they have so many other things to focus on. Particularly post-COVID, they face challenges on financial performance, workforce, quality, safety, cyber security, recruitment of physicians, and ways to improve healthcare access, etc. Research is generally not core to a community hospital’s mission.
What is an impactful message about clinical research as a care option to healthcare executives?
Clinical trials as a care option is a service to the patients they care for regularly. If executives set it up for success and manage the program well, it has been demonstrated that they can increase patient volume and enhance their brand and they can operate the program in a smarter way financially to get a return.
What most people don’t realize is that when a patient leaves their regular source of care to access a clinical trial at another hospital, they are often out of network for their health insurance and that means there will be a significant out of pocket cost they will need to pay. Many can’t afford this as it can be tens of thousands of dollars or more. This makes it more important for trials to be brought to the community and where the patients have their regular source of care.
What is the value of clinical trials being conducted in community hospitals, versus academic medical centers?
If we look at New York City as an example: there are people who would never venture into the city for healthcare or for whom the out of pocket cost is too high. In a place like Long Island where there is a population of over three million people, most go to their local community hospital and many of these hospitals offer very advanced care.
As part of that advanced care, it is important to bring trials to the patients and not expect the patients to travel for a trial. It takes executive level support and those executives have to understand that there is a business and mission case for offering trials and set it up for success.
"It takes executive level support and those executives have to understand that there is a business and mission case for offering trials and set it up for success."
What are the first steps for executives who are committing to bringing clinical trials to the point of care?
First, there has to be a mission and a business case for a community hospital. The executives have to say, “This is what we need to offer our patients and it is going to give us a competitive advantage. Our patients are going to go somewhere else if we don't offer them.”
The business case is threefold: one, that they can more fully serve their patients and retain them, two, they can attract and retain top physicians who want to offer leading-edge clinical care that includes clinical trials, and three, that they can run a profitable clinical trials program.
What do you encourage executives to consider when developing a business model?
When I develop a business model, I also say, “Let's look at the downstream benefits.” You need to calculate the monetary value of gaining or losing, for example, a cardiac patient, or identify the value of being able to recruit or retain physicians, if that’s something that you’ve had difficulty with, in the past. Make that part of your analysis.
To support physicians to offer clinical trials, which are more time-consuming than regular care, you also have to find ways of making it less of a burden and less time-consuming and factor in the additional time.
What is the model most community hospitals use to do clinical trials?
Usually for community hospitals, it’s physician-driven, rather than a program with an institutional commitment. The physicians advocate for clinical trials, and get the hospital to support them as best they can. This most often happens with cancer, because good cancer care includes access to clinical trials. Most physicians in cancer start with NCI trials. They are easier to manage because there is a fixed reimbursement rate and it’s not as complicated administratively or financially to set up. If a physician gets experienced enough with those, pharma may approach them and these trials have a better business case.
An option for community hospitals is to “buy” the infrastructure rather than build it since it is not a core competency in a community hospital. Companies like Javara or WCG have good models to consider and can help with functions like patient recruitment, developing budgets, contracts, etc.
"The business case is threefold: they can more fully serve their patients and retain them; they can attract and retain top physicians; and they can run a profitable clinical trials program."
What is the typical capacity and resources of these hospitals without external partnerships?
The challenge is that community hospital leadership isn’t aware of what “good” looks like when it comes to a clinical research infrastructure.
I was fortunate to have worked as an executive at MD Anderson Cancer Center before joining a community health system, so I was exposed to clinical trials early in my career. Most of our education and experience as executives does not teach us what clinical trial operations should look like, so we rely on physicians to tell us what is needed to bring clinical trials to the point of care and that has not resulted in strong enterprise-wide programs.
What trends/movements are you seeing in how clinical research is being offered as a potential care option?
The trend is to bring the best care close to where patients live. To that end, a lot of academic medical centers are taking over community hospitals. One of the goals is to bring academic-level medicine, and then clinical trials, to communities especially to reach underrepresented populations, but they really struggle with how to do that.
Academic medical centers (AMCs) have not been that successful exporting clinical trials because academic physicians have an expectation to participate in research and that is not the same for community-based physicians. When academic medical centers acquire or partner with a community hospital, the culture is still a community clinical culture. There are a few examples of healthcare executives who are embracing clinical trials and making them part of the way they deliver care in the community. Wilmington Health in North Carolina is an example where the CEO has made offering clinical trials the way they deliver care.
Can you expand on your previous comment about promoting physician participation in clinical trials?
AMCs have to bridge that gap and create a compensation model that is attractive to their community physicians.
If an academic physician sees patients three days a week in a clinic, and a community physician sees them five days a week, when an AMC brings trials into the community, they have to find a way to give these community doctors credit to accommodate for the fact that they’ll be seeing fewer patients.
What would be your final message to hospital higher-ups?
My broken record is reminding hospital executives that they can have a role in advancing science, and they can do so in a way that is good for them strategically.
We know that eighty-five percent of all cancer patients are seen outside of academic medical centers and that good cancer care requires access to clinical trials. It is probably the same for other clinical areas. If we have a large percent of those patients not being offered clinical trials, we’re never going to make fast progress on new treatments.
What would be your final message to trial sponsors?
Trial sponsors rely on AMCs because they clearly have the greatest capacity and expertise to conduct trials and advance discovery, but that is not moving the needle on increasing enrollment in trials and making trials part of care delivery. Community hospitals can support a robust clinical trials program and it is worth investing with them to create capacity for more trials.
We have to convince the organizations that take care of that 85% and Pharma that they need to work together to bring more trials to the community.
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