Over the years, the health system has built a robust research program, earning numerous awards and recognition for its accrual and performance efforts. In 2023, Sanford Health reported 1,318 total oncology trial enrollments, of which 1,080 were onto NCI-funded trials, followed by 164 investigator-initiated, and 74 industry-sponsored. Sanford Health is one of 34 community sites in the National Cancer Institute Community Oncology Research Program, where it was recognized for being in the top three for treatment trial accrual and cancer control, screening and prevention trial accrual.
One significant initiative to expand research access in the community setting is Sanford Health’s Teleoncology Program within its Gynecologic Oncology division. Telemedicine is a critical component of decentralizing clinical trials and making them more accessible for patients in remote areas or those who have limited capacity to travel to primary research sites. Through the Gynecologic Oncology Group, one provider at Sanford Health achieved approval to enroll patients from underserved areas into various clinical trials through telemedicine.
This setup allows the provider to operate at one site (Sioux Falls), travel to other locations, and conduct telemedicine visits with patients when she is not on site. The research coordinator can also be in a different location and still communicate with the patient via telemedicine. The telemedicine visits serve as follow-up appointments in between the patient’s routine lab monitoring and research treatments. Utilizing telemedicine has helped the gynecologic oncology team enroll more patients from different sites onto its NCORP trials and reduce the travel burden for trial patients.
Although the use of telemedicine has been a successful initiative thus far with NCI-funded gynecologic oncology trials at Sanford Health, the research program has struggled with the implementation of strategies to decentralize studies for industry-led trials. According to Jenna Hove, RN, BSN, Director of Research Operations at Sanford Research, industry-sponsored research protocols are often written in ways that do not accommodate decentralization of studies. For instance, the lack of flexibility in the location of lab work and imaging scans hinders the ability to conduct routine study monitoring at local sites. Sanford Health is actively seeking industry sponsors willing to support decentralized trials by developing more flexible and inclusive protocols.
For community oncology research programs that want to start decentralizing their trials, Hove recommends starting with the pieces that are easier to transition to the virtual space, such as follow-up visits or non-interventional trials, before tackling more logistically challenging components like drug shipment and treatment at local sites. Dr. Steven Powell, MD, Head of Enterprise Oncology Research at Sanford, notes that “if we can [treat patients locally and see them virtually] in the clinical setting, then we should figure out how we can do that for a study”.
In addition to study decentralization, bringing early phase trials into the community setting is another important step to expanding research access beyond large academic institutions. At Sanford Health, Dr. Powell leads the Phase I research program, which launched its first phase I study about 7 years ago. Dr. Powell recalls that it was initially very challenging to start the early phase research program, mostly due to lack of interest from industry sponsors. Companies may underestimate or may not understand the capability of community sites to conduct phase I trials, which is a limitation that should be addressed with education and advocacy on behalf of community programs. Although some community oncology sites may not have the resources to conduct early phase studies, many community programs do, and neglecting these patients from any phase of research only serves to diminish the strength and generalizability of the research findings (not to mention—reduces the treatment options for patients).
At this time, Sanford Health operates one of the only community-based dedicated phase I centers in the region. Having a phase I program allows Sanford Health patients to stay within the health system, decreasing the travel burden for patients and minimizing inefficiencies related to transfer of care. Phase I patients are primarily treated at the Sioux Falls site, where there is an outpatient phase I unit attached to the infusion center. For 24/7 acute care needs during early phase treatment, patients can be admitted to the inpatient phase I unit in the hospital across the street. On average, phase I patients are traveling about an hour to the site, but for those who are coming from much farther, there is a hotel or apartment complex close to the hospital where they can stay for longer durations.
Because there are limited options for phase I trials in the region, Sanford Health receives many referrals from community oncologists outside of the health system. For these patients and others within the health system, the phase I program aims to make the enrollment process as seamless as possible by utilizing remote patient screening and evaluation. The clinic employs an early phase nurse navigator and several clinical coordinators who interface with providers at other sites, collect patient information, and work with the phase I research team to remotely screen the patient. If the patient appears to be a good fit for a trial, then the nurse navigator will coordinate logistics to bring the patient to the primary site for an in-person evaluation.
Though it was not easy to establish the phase I program, the health system persevered and built a robust early phase research program that currently boasts 4 physician investigators and 14 active phase I studies. According to Dr. Powell, keeping the phase I program running throughout the pandemic helped boost it to where it is today, since many other early phase programs halted during the pandemic. For the short- and long-term future, Dr. Powell has his sights set on opening more trials and expanding reach of the early phase program by developing another phase I site at the Fargo Cancer Center.
All of these research endeavors would not be possible without strong institutional support and sufficient resources to carry out the research functions. The leadership team at Sanford Health recognizes the importance of staff training and has committed to developing the current and future workforce. Lora Black, RN, MPH, Vice President of Clinical Research at Sanford Health, has helped to establish a certificate program for clinical research in partnership with a local college to give students an introduction to research, where they have a structured course series mixed in with shadowing opportunities at Sanford Cancer Center. Sanford Health has also deployed its clinical research managers to visit local community colleges and give presentations about clinical research. The goal with these initiatives is to increase awareness about the opportunities within clinical research and to help new research staff jump into the workforce quicker.
As a regional hub covering a large geographic area (approximately the size of Texas), Sanford Health is in a unique position to bring cancer research to the community. Patients in rural settings are often underrepresented in research trials, but at Sanford Health, the research program is centered around providing options for these patients. In the view of the leadership, “cancer patients should be able to participate in trials and have access to state-of-the-art care close to home, reducing barriers such as time away from their family and vital support systems. By expanding trial availability, we can minimize their burdens.” There are still many barriers that the Sanford Health research program is working on overcoming, but they have undoubtedly set an empowering example of the potential for community oncology research to succeed when providers and leadership alike prioritize research in these patients.
