How an AMC Brings Clinical Trials to Patients in a Community Hospital
Dr Emily R. Ko, Duke Regional Hospital, and Denise Snyder, Duke University School of Medicine, describe how they leveraged the resources of the larger Duke Health System to bring clinical research into Duke Regional Hospital, and provide patients outside of the AMC with access to clinical trials.
When did you start to bring more clinical trials into Duke Regional Hospital?
Emily Ko: During COVID, there was an urgent need to bring the clinical trials to Duke Regional. Our population was being affected and the only treatments available were optional therapies through clinical trials. The concern was that we would have to send people away to other systems that could provide options for treatment.
The goal was to run clinical trials in-house at our community hospital, with a provider champion who understood the needs of both a community hospital and how to operationalize clinical trials. I actively recruited trials that covered gaps in COVID-19 therapies to give our patients access to these options.
The pharmacy director and I partnered to open therapeutic clinical trials at Duke Regional. We didn’t have the financial infrastructure for clinical research, so we looked to the Department of Medicine and other clinical research units to support the funding.
What was the biggest challenge in bringing trials into the community hospital?
EK: The biggest barrier for therapeutic trials is investigational pharmacy resources, because that's a very different type of pharmacy than clinical pharmacy. We tried to expand into clinical research in a way that was sustainable for us, using and repurposing existing resources.
Other health systems have instituted investigational pharmacies within their satellite hospitals, which takes a lot of time and resources. Being closer to the larger investigational pharmacy at the Duke University Hospital allowed us to come up with creative models, and avoid wasting excess time and unnecessary resources.
"We tried to expand into clinical research in a way that was sustainable for us, using and repurposing existing resources."
What was the end solution for an investigational pharmacy?
EK: We ended up developing a hybrid system. The investigational pharmacy at Duke does all of our research-based randomization, tracking, etc, and trains our pharmacists for each of the trials they’re going to perform.
Our clinical pharmacists were trained to be blinded and distribute medications. They prepare what they are told to prepare, deliver it to the unit, but all of it is pre-labeled and brought over from the investigational pharmacy. Our clinical pharmacy performs all of the temperature tracking and anything else that would be necessary to maintain these services on site. Many of these are already necessary for clinical pharmacy operation.
Denise Snyder: This is where the combination of having some infrastructure at larger Duke University Hospital and in the School of Medicine allows us to more easily ask, “What do we need to do to help make some trials happen?”
What did you learn about the process of working with Duke Regional?
DS: First, that it is much easier for our potential participants to navigate the community hospital than to come over to the University hospital setting. It can be physically strenuous to do all that walking for participants, and it can be confusing to navigate.
Second, we learned that we need to create an engine, rather than everyone coming up with their own workflow. However, coming from the larger research environment, you have to recognize the differences present at a community hospital and work with those. Working with Emily helped us to understand how things worked at Duke Regional, and how we could best engage the staff there.
The challenge with clinical research has always been that clinical research coordinators would come into the hospital, having to navigate the hospital without getting in anyone’s way. One of the struggles we heard from our coordinators was, “I want to go and work out of Duke Regional, but I have nowhere to go in between patient visits.” Before, they had to travel back and forth between sites, with the hope that they might enroll a patient on any given day.
“What do we need to do to help make some trials happen?”
How did you solve the challenge of coordinators having the proper space and resources when coming into the regional hospital?
DS: We created a location on-site at Duke Regional where our coordinators could work between participants. We have a service center team to deploy staff as needed. Now, we have the ability to use our central team and say to them, “You’re working on 3-4 trials and they’re all going on at Duke Regional. You can work from there this week.” In making the jump from the University Hospital setting to the smaller community hospital, we also need our staff to slow down a little bit and be ready whenever that page comes through.
When we talk about creating an engine, that’s what we’re referring to: creating a system where you don’t have feast-or-famine, which isn’t good for coordinators or investigators. If you don’t create that system, no one gets enrolled, and we’re spending money, but not capitalizing on accessing clinical trials.
How has your clinical trial infrastructure evolved to today?
EK: Most of the trials we bring to Duke Regional are pragmatic studies and Phase II/III studies that have preliminary data to support them. We have focused on improving access to on-site research space, pharmacy infrastructure and support, and improved funds flow. Some tangible examples of these changes are research office space, equipment for a lab processing space, and five-year space expansion plans in areas like pharmacy.
We have expanded into surgical trials utilizing devices and robotics, suicide prevention trials for our psychiatry teams, trials for biomarkers in the Emergency Department and Critical Care, and continued therapeutics in multiple areas.
We have developed a model where trials can share a coordinator to allow them to have dedicated time at Duke Regional, although many trials still utilize a coordinator stationed at Duke University Hospital that come to Duke Regional to perform enrollments.
"we learned that we need to create an engine, rather than everyone coming up with their own workflow."
How do you engage providers?
EK: When trial teams reach out to attending providers they are able to explain the gap in knowledge and if the provider is interested they can also get educated about the data behind the research question.
We utilize research champions that can discuss trials at departmental meetings. I have given Duke Regional Grand Rounds and talks to our Executive Leadership Team. Additionally, our hospitalist group discusses these issues in our journal club and group meetings where trial teams have reached out to present. Trial teams also post flyers in clinical areas they will be operating to encourage staff familiarity. It is starting to become part of the Duke Regional culture as an academic community hospital, rather than an anomaly.
How do patients find out about clinical trials that they could participate in?
EK: Our coordinators screen the entire health system and find patients, whether they are located at Duke Regional or in the larger University hospital.
When it comes to Duke Regional, trial teams reach out to the attending physician and inform them about a potential trial. Research champions are key to a successful process. For one of our trials, which went through the emergency room, the chief of that department was a sub-investigator. For many of the patients who consented, he was part of their clinical care, notified the research nurse of patient interest in participating, and got the process started.
What’s next?
DS: My team is looking at other community-related engagement efforts. One of those efforts is a website that makes it easier to find and learn information about Duke trials. Previously, the clinical trials directory that the health system was responsible for wasn’t patient-friendly, or easy to navigate. Duke University School of Medicine, in partnership with the Duke Clinical and Translational Science Institute (CTSI) and the Duke Office of Clinical Research (DOCR), has launched a new community-facing website about clinical research.
My Duke Research serves as a searchable directory of clinical studies and trials at Duke, offering a variety of filters to quickly find enrolling studies by location, health condition, keyword, and more. The new site also provides helpful information about clinical research, shares updates about current studies and research results, and highlights the connection between health research and community health.
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