ACORI Research Review: September 2024

Short for “We’re in This Together”, the WiTT Registry was founded in 2021 by Rahul Mahadevan, a seasoned executive in the health care industry who experienced his own battle with prostate cancer during the pandemic. While going through treatment, Rahul realized that there was a big disconnect between patients’ expressing their needs and communities addressing those needs in a helpful way. Patients often do not want or do not know how to ask for help directly, even though they need it. In a similar vein, those acquainted with a patient may want to provide support but are not sure how to. What further complicates this dynamic is that a patients’ needs are constantly changing as they go through different phases of treatment—what is relevant one day may not be as pertinent the next.

After personally struggling with these challenges and meeting many patients who faced similar difficulties, Rahul was inspired to create a platform that would help patients meet their needs. The goal of the WiTT Support Registry is to alleviate the non-clinical burdens that patients experience by allowing them to pinpoint specific needs for various aspects of daily living. Unlike most crowd-sourced fundraising platforms, in which donors contribute a dollar amount to the overall cause, funds in the WiTT Support Registry are allocated for distinct purposes—similar to having a wedding registry, but for needs related to cancer care. For example, patients may register for $100 of groceries, $50 for the gas and electricity bill, $80 for self-care, or $500 for medical expenses. Delineating exact needs establishes transparency and creates a more personalized approach to supporting a patient.

In addition to registering for funds, patients can also register for activities such as help with mowing the lawn, providing a ride to treatment, going for a walk, or childcare, for instance. The WiTT Registry makes it easy for supporters to know exactly how to help the patient. In the event that donors or organizations want to give a lump sum donation without designating a specific patient, this would be tax deductible through the non-profit arm of the WiTT program. In these cases, the WiTT group would disburse the funds to the patients. Donations made directly to patients are seen as gifts and are not tax deductible. One hundred percent of funds donated to a patient is given to the patient; there is no fee to the patient when transferring the funds. Donors have the option of paying an adjustable service fee to the WiTT Registry. For its other operating costs, the WiTT group works with various health care organizations to sustain its operations.

What further sets the WiTT Registry apart from other crowd-sourced fundraising platforms is that it can be used to address health equity concerns by compiling social determinants of health (SDoH) data from patient registries. The platform is essentially a database where different types of data can be pulled to better understand patient needs. For example, what are the most common subcategories of needs (i.e. groceries, mortgage/rent, utilities, insurance copays, etc.)? What is the patient distribution by ethnicity? What are the most common disease states and stages in the registry? With this repository of real-world data, the WiTT Registry is able to gain unique insights into a range of patient needs based on different demographic categories.

Not only can the WiTT Registry benefit patients, but it can also provide value to various healthcare stakeholders. For health care organizations, the WiTT Registry can play an integral role in facilitating direct support to patients by leveraging community engagement, ultimately leading to better outcomes for patients. Pharmaceutical companies and contract research organizations may use the WiTT platform to improve access to trials by proactively mitigating financial and logistical barriers and enhancing diversity action plans with SDoH data generated by the registry. As a white label platform, the WiTT Registry can be adapted to various organizations to drive loyalty and adoption. Providers who are interested in the WiTT Registry can contact the WiTT group for more information or direct patients to create a profile in the registry. Although only a few years old, the WiTT platform has already transformed the lives of many patients and continues to be a powerful resource during a patient’s cancer journey.

Over the last several decades, the treatment landscape for blood cancers has evolved drastically with the advent of targeted therapies, antibody-drug conjugates, immunotherapies, bispecific antibodies, and chimeric antigen receptor T-cell therapies. What would have been a death sentence 50 years ago is no longer as imminently fatal today for the majority of patients due to the robust advancements in treatment options. However, there are still many opportunities to improve the disease trajectories and find that elusive cure. Disease relapse, treatment resistance, cancer genomics, and other topics all remain active areas of opportunity in blood cancer research.

One purpose of Blood Cancer Awareness Month is to provide education on the importance of participating in clinical trials. It is estimated that less than 10% of patients with cancer participate in clinical trials. A range of barriers contributes to this low proportion, many of which are modifiable but require significant prioritization and accountability from healthcare stakeholders. Matching patients to suitable trials can often be overwhelming for patients and providers alike, especially at smaller community practices that have fewer resources. To help increase access to clinical research for patients with blood cancers, the Leukemia and Lymphoma Society (LLS) created a Clinical Trial Support Center (CTSC) in 2016, where patients can work one-on-one—at no charge—with an LLS Clinical Trial Nurse Navigator to identify trials for their unique situation.

The goal of the CTSC is not necessarily to enroll every referred patient on a clinical trial, but more so to enhance awareness and education surrounding clinical trials, promote shared decision making between the patient and the provider, and help mitigate barriers to trial participation. Patients can call in to the program themselves or be referred by their oncology team. When working with the patient or caregiver, the nurse navigator focuses on seven different patient-centered service components, consisting of medical history and status, psychosocial factors, education about clinical trials, personalized trial search and matching, decision support, assistance with connecting to clinical trial sites, and provision of ongoing support to resolve barriers to participation.

A retrospective analysis of the CTSC program was conducted to evaluate cases between October 2017 and October 2019. Among 750 cases, 21.3% had no clinical trial search conducted, primarily because the patient or caregiver decided not to proceed further. In a handful of cases, the nurse navigator deemed the patient medically unfit for a trial search. Patients who had relapsed or refractory disease were more likely to have a trial search conducted than other treatment statuses (active treatment, maintenance, etc.). 537 patients had a known enrollment outcome; of these, 22.5% enrolled in a trial with assistance from CTSC.

Clinical trial enrollment rates differed significantly by insurance type (Medicaid patients were less likely to enroll in a trial), treatment status, ECOG performance status, and urban or rural residence. The reasons for patients not enrolling in a trial with help from CTSC included preference for standard of care (66%), deceased status (16%), did not meet eligibility criteria (7%), trial treatment modality not compatible with patient preferences (3%), insurance constraints (2%), no trials within local geography (2%), chose compassionate/off-label use (1%), unknown (1%), and financial constraints other than insurance (0.2%). Overall, the CTSC can serve as a valuable tool for patients battling blood cancers and providers are encouraged to share this and other resources during Blood Cancer Awareness Month (and thereafter!).

In 2021, the United States Preventive Services Task Force updated its recommendations for lung cancer screening via low-dose computed tomography (LDCT) to include adults aged 50 to 80 years with a 20 pack-year smoking history who currently smoke or have quit within the past 15 years. Previously, the screening recommendations had been more restrictive and applied to adults aged 55 to 80 years with a 30 pack-year history. The expansion of screening recommendations resulted from an extensive data review that established a starting age of 50 years and smoking history of 20 pack-years to be a more efficient and inclusive screening strategy.

Compared to the 2013 criteria, the 2021 criteria have reduced disparities in lung cancer screening for various groups of patients. A review of the North Carolina Lung Screening Registry from January 2015 to September 2023 found that the expanded criteria enabled a greater proportion of female participants (56.1% vs. 48.1%), non-Hispanic Black individuals (19.3% vs. 13.4%), individuals currently smoking (71% vs. 52%), and individuals with a primary care clinician who ordered lung cancer screening exam (69.2% vs. 62.7%) to be screened compared to previous criteria. Notably, a majority of patients (83%) became eligible due to the reduction in pack-year smoking history. Most importantly, the expanded criteria were associated with a significantly lower risk of developing and dying from lung cancer per 1000 people (median risk of developing lung cancer: 19.0 vs. 39.6; risk of dying from lung cancer: 10.7 vs. 26.4).

Studies from Smeltzer et al., Ritzwoller et al., and Pu et al. reported on similar findings of the 2021 updates leading to a more racially inclusive group of patients being screened. In the Population-based Research to Optimize the Screening Process (PROPSR) Lung Consortium, which includes 5 community-based health care systems throughout the US, the 2021 recommendations enhanced screening eligibility by more than 50%, of which the relative increases in proportion of newly eligible individuals were 11.6% for Asian, Native Hawaiian, or Pacific Islander; 18.4% Hispanic; and 20.7% non-Hispanic Black, compared to non-Hispanic White individuals. Overall, a 30% increase in lung cancer diagnoses was observed with the broadened eligibility criteria.

Smeltzer et al. analyzed the clinical stage distribution of the additional patients meeting updated screening criteria who were eventually diagnosed with cancer and found that 34% were diagnosed with stage I disease, 4.5% stage II, 15.9% stage III, and 31.8% stage IV. In comparison to historical data of stage distribution, the findings from Smeltzer et al. demonstrate how the expanded screening criteria can capture patients at earlier stages of disease, ultimately leading to better outcomes. Without all of the pivotal research trials prompting a change in the screening guidelines in recent years, many patients—particularly females and non-Hispanic Black individuals—would continue to be missed opportunities in earlier diagnoses of lung cancer.

Reducing the overall burden of lung cancer and death from lung cancer requires a multi-pronged approach. Smoking cessation is the single most important intervention to reduce the risk of lung cancer and should go hand in hand with screening. Studies have shown that combining screening and smoking cessation efforts is more effective than using either modality alone. A simulation study of a Northeast Pennsylvania population determined that screening or cessation alone could achieve an estimated mortality reduction of 1.9% or 7.1% by 2050, respectively, while a combined strategy would lead to an 8.2% reduction.

In another simulation model, the authors concluded that for screening efforts with 10% to 100% uptake, the percent reduction in lung cancer deaths with additional cessation programs ranged from 3% to 52% (for cessation effectiveness of 5% to 25%), and the percent increase in life years from 40% to over 200%. It should be noted that as these studies were published before 2021, they do not reflect the 2021 screening guidelines; presumably, the impact on mortality with combined cessation could be even greater with the updated screening guidelines.

Combining pharmacological interventions and behavioral therapy is the most effective smoking cessation strategy and is the gold standard in cessation treatment. In regard to pharmacological therapy, a nicotine receptor agonist (varenicline) has been shown to be more effective than bupropion (abstinence rate of 44% vs. 29.5%) in smoking cessation, and combining varenicline with nicotine replacement therapy can induce the highest rate of continued abstinence.

In the community setting, the Courage-To-Quit® program—which incorporates an orientation and psycho-education sessions surrounding cessation interventions and behavioral therapies—has been a successful program with high acceptability (>90%) and feasibility (53% - 75%) rates and encouraging quit rates (22% - 36% among those who completed the program). Among an underserved low-income Black population, 52% of participants attended at least 2 sessions and 24% completed the entire program. Those who completed the program reduced their average daily cigarette intake significantly more than non-completers (reduction of 4.6 vs. 1.3 cigarettes/day).

In honor of Lung Cancer Awareness Month and National Smoking Cessation Month every November, it is important to reflect on the impact that screening and cessation efforts have had on reducing the overall burden of lung cancer. However, we still have a long way to go. Rates of lung cancer screening remain low among the eligible population, and smoking cessation rates are far from high. Ongoing work in this area revolves around understanding and mitigating barriers to access to screening and developing new tools for cessation. To increase exposure to screening and cessation, providers are encouraged to share the Lung Cancer Screening Resources and Freedom From Smoking (and other cessation programs) with patients and caregivers in promotion of Lung Cancer Awareness Month.

“Oncology is distinct from other medical specialties in that clinical trials are an integral part of the standard of care,” explains Al Benson, MD, professor of medicine and associate director for cooperative groups at Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Dr. Benson emphasizes that quality patient care demands the seamless involvement of APPs in clinical research.

Despite this, challenges remain that prevent many APPs from taking on a more prominent role in clinical trials. Christa Braun-Inglis, DNP, nurse practitioner, assistant researcher, and CCDR lead at the University of Hawaii Cancer Center highlights that a 2020 survey of over 400 APPs revealed that >90% believe they should be more involved in oncology clinical research. However, logistical and operational barriers must be addressed to fully integrate APPs into this role.

Practical Solutions: APPs in Clinical Research Manual and Virtual Workshop

To overcome these barriers, Benson and Braun-Inglis collaborated to create the Advanced Practice Provider (APP) Clinical Trials Research Manual. Sponsored by ECOG-ACRIN, the manual provides a comprehensive overview of the structure needed to involve APPs in clinical research at community cancer centers. Key topics include:

• Types, phases, and endpoints of clinical trials
• Research team roles and responsibilities
• Protocol development review process
• Regulatory affairs and data management
• Enrollment and informed consent processes
• Auditing and monitoring
• National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) APP prescribing policy
• Tips for discussing trials with potential participants.

Another important educational initiative is the Southwest Oncology Group (SWOG) virtual Advanced Practice Provider (APP) Clinical Research Workshop, which offers 3 continuing medical education (CME) credits (via the HOPE foundation). The workshop contains the following components:

• Module 1: Overview of NCI-sponsored research: National Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP)
• Module 2: How do I become a non-physician investigator (NPIVR)?
• Module 3: Different types of protocols for APP participation
• Module 4: Cancer control and cancer care delivery research protocols: roles of APPs
• Module 5: Overcoming barriers and exploring facilitators of APPs in research
• Module 6: Opportunities for increasing involvement of APPs in research bases
• Module 7: Protocol implementation: the details.

Meaningful Policy Change

These efforts have led to recent policy changes at the national level. A significant barrier to NCI-funded clinical trial accrual was the requirement for a physician investigator’s co-signature on orders for investigational new drugs in the context of a clinical trial. As of September 2021, the NCI Cancer Therapy Evaluation Program (CTEP) and NCORP issued a memorandum marking a pivotal shift in policy: qualified APPs may now write patient orders for study agents without requiring a physician investigator’s co-signature. These APPs must be registered in NCI’s registration and credentialing roster (RCR) as non-physician investigators (NPIVRs). Additionally, the NCI Divisions of Cancer Prevention (DCP) and Cancer Control and Population Sciences (DCCPS) developed a 2021 guideline allowing APPs to take on an enhanced role in the development and implementation of NCORP-funded research endeavors, serving as chairs, co-chairs, and local investigators qualified to consent and enroll patients.

The Importance of Recognition

When asked what would encourage more APPs to engage and remain active in clinical research, Braun-Inglis emphasizes the importance of recognition. Acknowledging the unique role and contributions of APPs to clinical research at the institutional and professional organizational level would reinforce participation efforts, elevate the role of APPs in oncology care and clinical research, and inspire others to become involved as well.

A review of recent research reveals the use of AI is increasing in health care to assist in early diagnosis, predict disease progression, and identify high-risk individuals. For example, note-taking with AI has been shown to increase provider productivity and time spent on patient care.² Additionally, computer vision is being used to interpret images and videos as good as or better than humans, making up for significant workforce shortages.³ One example of this is the Smart Tissue Autonomous Robot (STAR) from John Hopkins University, which has outperformed human surgeons in some procedures.

The potential impact of AI on health care spending is estimated to result in total savings of $200 to $360 billion over the next 5 years.¹ Estimates show private payers could see annual savings of $80 to $110 billion over the same period.⁴ This cost savings is a result of streamlined processes and the automation of repetitive tasks, which improves efficiency and reduces administrative burdens on health care providers. As AI use continues to grow in the health care industry, the cost implications and financial impact on providers and patients will become clearer.

While AI has many benefits, it is also feared for lack of control. Providers are using (unregulated) tools such as note-taking virtual assistants and predictive software to support patient diagnoses and treatment.⁵ Proponents of more regulation argue that unregulated use of AI could lead to increased chances of data breaches, bias and discrimination from AI algorithms, and the provision of medical advice that is misleading or false.⁶

It is crucial for providers and health care organizations to ensure regulatory and ethical compliance in using AI. Some best practices to consider in protecting data, mitigating risk, and regulating the use of AI include⁷

• Define a broad view of AI compliance:
  
  With the constant change surrounding AI regulation and compliance, organizations must develop processes and procedures to monitor and measure compliance to meet applicable requirements. There are various toolkits that can be found online to support an organization’s systemic approach to AI compliance to ensure consistency across the organization.
• Keep up to date on the latest information on AI compliance:
  
  This recommendation refers to awareness and understanding of the regulations regarding AI use, including government laws, international standards, or internal organizational policies.

In October 2022, The White House released a Blueprint for an AI Bill of Rights that identified key principles in addressing risks associated with AI use.⁸ The U.S. Department of Commerce’s National Institute of Standards and Technology also introduced the Artificial Intelligence Risk Management Framework 1.0 in 2022, as a guide on responsible AI development.⁹ Additionally on June 14, 2023, the European Union released the Artificial Intelligence Act (AI Act) - the first legal framework on AI addressing AI risks.¹⁰

It is important to regularly monitor changes in AI rules and regulations. Consider joining an organization that offers peer support and regular regulatory updates delivered to your in-box such as the Health AI Partnership.¹¹

• Enable AI compliance mapping:
  
  An organization can be subject to several various AI authoritative rules. This can make it difficult and time-consuming to track the AI requirements that need to be addressed. Compliance mapping refers to developing a plan to monitor common AI requirements that need to be addressed as well as supplemental ones that can be addressed as needed. Organizations can use in-house compliance mapping or a third-party AI compliance tool to predict and suggest data field mapping relationships and transformation rules, alleviating errors and manual tasks.

There is no question that AI use in health care will lead to transformative and disruptive advances. It is important for organizations to have a thoughtful and inclusive AI plan that manages and reduces potential unintended consequences. This is not an easy task. It will take buy-in across the organization as well as collaboration among various teams. Organizations that make the investment in time and resources will not only see risk mitigation, but also an efficient adoption of new technologies. In a rapidly changing landscape, ensuring best practices are used for compliance and ethics serves as a cornerstone of integrity, accountability, and trust.

References:

1. Sahni N, Stein G, Zemmel R, Cutler DM. The potential impact of artificial intelligence on healthcare spending. Working Paper. Published online January 2023. Retrieved 08/11/2024, from https://www.nber.org/papers/w30857
2. CliniScripts. Revolutionizing Healthcare: How ai is transforming note-taking practices for better patient care. LinkedIn. February 5, 2024. Accessed August 18, 2024. https://www.linkedin.com/pulse/revolutionizing-healthcare-how-ai-transforming-note-taking-5i1if/.
3. Bohr A, Memarzadeh K. The rise of Artificial Intelligence in healthcare applications. Artificial Intelligence in Healthcare. 2020. Accessed August 18, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325854/.
4. Kasyanau A. Balancing the cost of AI in healthcare: Future savings vs. current spending. Published April 2024. Retrieved 8/17/2024, from https://www.forbes.com/councils/forbestechcouncil/2024/04/17/balancing-the-cost-of-ai-in-healthcare-future-savings-vs-current-spending/#:~:text=The%20big%20question%20for%20healthcare,the%20next%20five%20years%20(pg.
5. Reader R. Artificial intelligence is making critical health care decisions. The sheriff is MIA. Published online 02/18/2024, accessed 08/11/2024, from https://www.politico.com/news/2024/02/18/artificial-intelligence-health-care-fda-00141768
6. Rahman A, Victoros E, Ernest J, David R, Shanjana Y, Islam R. Impact of Artificial Intelligence (AI) Technology in Healthcare Sector: A Critical Evaluation of Both Sides of the Coin. Clinical Pathology. Published online January 2024. Retrieved 8/17/2024, from
7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10804900/
8. IBM. Five best practices to improve compliance with AI regulations and standards. Published September 2021. Retrieved 8/17/2024, from https://www.ibm.com/blog/five-best-practices-to-improve-compliance-with-ai-regulations-and-standards/
   
9. The White House. Blueprint for an AI bill of rights: Making automated systems work for the American people. Published October 2022. Retrieved 8/17/2024, from https://www.whitehouse.gov/wp-content/uploads/2022/10/Blueprint-for-an-AI-Bill-of-Rights.pdf
10. U.S. Department of Commerce, National Institute of Standards and Technology. Artificial intelligence risk management framework (AI RMF 1.0). Published January 2023. Retrieved 8/17/2024, from https://nvlpubs.nist.gov/nistpubs/ai/nist.ai.100-1.pdf
11. European Commission. AI act. 2024. Retrieved 8/17/2024, from https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
12. health ai partnership. About Us. Published 2023. Retrieved 8/17/2024, from https://healthaipartnership.org/about-ai-health-partnership

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.