ACORI Research Review: October 2025

Perkins outlined the scope of her role, emphasizing that nurse practitioners in the novel therapeutics setting “function in the same aspect in the clinic as a physician does. We see patients, we diagnose them.” Her duties extend beyond the standard APP role, including signing off on study drugs, participating in safety review committee meetings, and representing patients in eligibility and safety discussions.

What sets her role apart is her deep involvement in interventional procedures. “One of the things I do that the physicians are capable of, but I handle, are the tumor injections we have for new sorts of cancer,” she explained. She is also certified to perform skin punch biopsies, allowing the clinic to meet procedural requirements for advanced trials without relying solely on physicians.

Identifying Gaps and Implementing Solutions

Before the development of the NTC, several key issues hindered clinical trial efficiency. Out-of-state patients frequently traveled for consultations only to screen fail due to criteria that could have been identified earlier. Tissue prescreening processes were disorganized, and screening procedures took excessive time, delaying patient access and consuming valuable resources. To address this, Perkins said she “took it upon [her]self to be the person to screen everybody.” She reviews inclusion and exclusion criteria, evaluates eligibility, and documents findings directly into the electronic health record (EHR). This shift has streamlined the screening process and prevented unnecessary visits, preserving both institutional and patient resources.

To further standardize care, Perkins collaborated with Epic EHR specialists to build clinical note templates that are now uniformly used across the clinic. These templates improve communication among rotating providers and support data extraction for tracking trial enrollment and outcomes.

Consistent Continuity of Care

A major challenge in the NTC’s early operations was the lack of continuity of care. With physicians rotating through the clinic, it was difficult to maintain consistent knowledge of patient histories and ongoing treatments. As the only full-time APP, Perkins now serves as the clinic’s anchor. “I’m the constant. If something happened in a visit and somebody else is seeing them the next week, I can say, ‘This is what happened, this is what we did, we need to follow up on that.’ ” Her role ensures smooth handoffs, consistent follow-up, and stability for patients in complex trials.

APPs as Leaders in Oncology Innovation

Perkins underscores that APPs can and should take on broader responsibilities in clinical trials, especially within novel therapeutics. Beyond clinical care, APPs can contribute to research, lead workflow improvements, support technology integration, and serve on safety committees. These roles enhance patient care and place APPs at the forefront of clinical innovation. “I encourage [professionals interested in this work] to become a certified oncology NP,” she said. The Advanced Oncology Certified Nurse Practitioner (AOCNP) certification is to solidify clinical expertise and signal a commitment to high standards in cancer care.

Looking Ahead

The future of the NTC is bright, with ongoing efforts to scale the program and increase trial availability. Perkins envisions a robust clinic staffed with more APPs, expanded nursing roles, and a wide portfolio of trials accessible to any patient who qualifies. “Anything that you see that could be better or improved, figure out a way to do it…you can always improve on something,” she said. A new data dashboard is in development to track patients across the trial continuum using standardized documentation. In summary, Perkins’ leadership in the NTC illustrates how APPs can drive systemic change and elevate the standard of care in complex oncology environments.

A Seamless, Patient-Centric Vision

Kottschade describes Clinical Trials Beyond Walls as a bold effort to dismantle the geographic and logistical barriers that often prevent patients from participating in clinical trials. “Our vision is to provide a seamless, patient-centric, equitable clinical trials experience using innovation to make clinical trial access more efficient,” she said. The ultimate goal is to increase access to trials for patients across the country and around the world, and in doing so, improve the ability of clinical trials to advance the standard of care in oncology.

The initiative is anchored on 4 objectives:

1. Optimize the study participant and research team experience, making trials easier to navigate.
2. Expand access beyond large academic medical centers to reach rural communities and those outside the immediate area surrounding Mayo Clinic.
3. Foster inclusion across diverse geographies, cultures, and demographics.
4. Simplify operations for research teams with best-practice workflows and support.

Mayo Clinic has 3 core teams focused on this mission:

• The Data Team works on near real-time data collection and ensures that both patients and researchers can access and utilize that data effectively.
• The Product Team develops and integrates tools such as telehealth visits and remote specimen collection into a flexible trial framework, supporting a wide range of study types.
•  The Operations Enablement Team is the bridge between researchers and technical experts, helping study teams incorporate these tools with hands-on guidance.

These 3 groups work in synergy to transform traditional trial models into dynamic, patient-friendly systems.

The Foundational Toolkit and Consult Service

One of the key strengths of the Clinical Trials Beyond Walls program is its foundational product tool kit: a suite of decentralized approaches that can be tailored to any trial. These include:

• Remote consent via video with electronic signatures
• Video visits for virtual follow-ups
• Remote biospecimen collection for blood, saliva, urine, and more
• Device services for loaner tablets or wearables
• Remote patient monitoring through apps or connected devices
• Medication delivery to the patient’s residence. Though initially focused on oral therapies, there are plans to expand to intravenous and subcutaneously administered medications.

Supporting this tool kit is a consult service that works directly with study teams to review protocols and identify opportunities to integrate decentralized elements. Kottschade emphasized that this isn’t a one-size-fits-all approach, “One thing I want to highlight is that remote capabilities aren’t for everyone. [Remote capabilities] are not requirements by any means, [nor are they] the only solution, but an [opportunity to] supplement the protocol with these options so that patients have more flexibility,” she said.

Success Stories and Lessons Learned

Early pilot programs with 4 study teams yielded valuable insights. By supporting teams from protocol development through patient enrollment, Kottschade’s team was able to refine workflows in real-time. “We saw where there were gaps in understanding or needs from study team members who may have not utilized that technology. We found what are the training materials that we need to put in place for the study team and that the patient might need,” she said.

Patients have embraced the flexibility. One notable example: replacing a 3- to 4-hour round-trip visit to Mayo with a 15-minute in-home blood draw. “That’s real impact,” Kottschade said.

Challenges remain, particularly in adapting standardized tools to the unique nuances of each study. But the team continues to strike a balance between consistency and customization. To scale the program effectively, Mayo Clinic has developed capability-specific resource guides, a protocol template with institutional review board (IRB)–friendly language, and self-service tools that empower researchers to adopt decentralized methods independently.

The team is also collaborating with Mayo Clinic Platform to enhance its technology capabilities and expand the program. Mayo Clinic Platform is a digital health initiative that leverages de-identified clinical data, advanced analytics, and global collaborations to accelerate the development of AI-driven tools and solutions. Its goal is to make healthcare more predictive, personalized, and accessible while ensuring privacy, security, and ethical use of patient information.

Looking Ahead

Kottschade envisions a future where these tools are not only widely adopted at Mayo, but also shared with the broader research community. “We’re looking at how can the things that we’ve learned support the industry and support the adoption of decentralized capabilities across any organization, not just Mayo Clinic,” she said. By removing physical walls, Clinical Trials Beyond Walls is also tearing down the metaphorical ones—broadening who can participate in research, and how. The result is a smarter, more inclusive, more responsive research ecosystem.

Epic’s Research Module is designed to support the full spectrum of clinical research activities, from study build and patient screening to visit scheduling, documentation, and billing compliance. When thoughtfully implemented, it can streamline research workflows, enhance regulatory oversight, and help ensure that clinical research is conducted efficiently and ethically—without disrupting day-to-day patient care.

Integrating Into Community Oncology Operations

Unlike academic medical centers, community oncology practices often lack dedicated infrastructure for clinical research. Staff members may wear multiple hats, and clinical workflows need to be as streamlined and integrated as possible. Epic’s Research Module is particularly well-suited for these environments, as it embeds research functionality directly into the EHR workflows that staff already use for clinical care.

For example, once a study is built within the system, clinicians and coordinators can access protocol-specific order sets, visit schedules, and documentation templates within the same Epic environment used for routine care. This reduces the need for double documentation or toggling between systems—critical for sites with limited research staff.

Identifying and Enrolling Eligible Patients

Recruitment is often the greatest barrier to successful trial activation in the community setting. Epic’s Research Module helps address this challenge through built-in tools for patient identification and enrollment. Stephanie Farrell, MBA, RN, CCRC, OCN, director of research administration at Eisenhower Health highlighted a particularly useful feature: a dashboard that tracks progress toward trial enrollment goals. The dashboard displays the number of patients who are potentially eligible, screened, awaiting informed consent, and enrolled, offering real-time visibility into recruitment efforts.

Providers can receive alerts to their inbox when a patient meets eligibility criteria for an open study, based on diagnosis codes, lab results, performance status, or other structured data in the EHR. These flags can help clinicians identify appropriate patients during regular visits, avoiding missed opportunities for trial enrollment.

In addition, Epic supports documentation and tracking of informed consent—either in-person or electronically—so that sites can ensure compliance with regulatory requirements while maintaining clear, auditable records.

Supporting Standard of Care vs Research Billing

One of the most complex aspects of research implementation is differentiating between services that are part of routine care and those that should be billed to a study sponsor. This is particularly important in oncology, where patients often undergo frequent labs, imaging, and treatment visits—some of which may fall under research protocol requirements.

“Ensuring the National Clinical Trial (NCT) number is documented as part of the claim is especially important,” Farrell said. Epic’s Research Module supports billing compliance by tagging study-related orders and visits accordingly. When linked with research billing review workflows, this functionality can help prevent inappropriate charges to third-party payers and support Medicare’s Clinical Trial Policy. For community sites participating in industry-sponsored or cooperative group trials, this capability reduces the risk of billing errors and financial penalties.

Coordinating Research Visits With Clinical Care

Epic’s integration of research visit schedules within the patient’s broader care plan is especially valuable in oncology, where protocol-defined assessments must align with the patient’s existing treatment cycle. Research coordinators can view upcoming study windows, required labs, and assessments directly in Epic, helping them align visits and avoid protocol deviations.

The platform also supports operational efficiency by allowing research tasks—such as quality-of-life questionnaires and patient-reported outcome assessments—to be assigned to specific staff members. Programmable templates for research notes and adverse event reporting are also available within the module, supporting complete and compliant documentation that can be easily audited or shared with sponsors and regulatory bodies.

Laying the Foundation for Growth

Even for community oncology programs just beginning to build out their research portfolios, implementing Epic’s Research Module lays the groundwork for scalable, efficient operations. The module can support studies of all types—including observational registries, cooperative group trials, and industry-sponsored therapeutic studies.

In many cases, the module can also integrate with external clinical trial management systems. This can be especially valuable for sites affiliated with academic partners or cancer networks, allowing for centralized protocol management while preserving local EHR integration.

A Strategic Investment in Access and Equity

Expanding access to clinical trials in the community setting is not just a matter of operational efficiency, it’s a question of equity. Most patients with cancer in the US receive care in the community, yet only a small fraction have access to clinical trials close to home. By leveraging tools like Epic’s Research Module, community oncology programs can play a key role in changing that dynamic.

With the right support and planning, implementing Epic’s Research Module can help demystify research operations, ease clinician burden, and ensure that more patients have access to innovative therapies without needing to travel far from their support systems. As more cancer centers look to bridge the gap between clinical care and research, Epic’s Research Module offers a critical piece of the puzzle—bringing trials to where patients are, and making research a natural extension of high-quality, patient-centered cancer care.

Currently, the Big Ten CRC comprises 16 universities, with a few more potential memberships in discussion. Each cancer center brings its unique strengths to the collective impact, providing a robust and comprehensive scope of research areas. The member institutions specialize not only in clinical research but also, importantly, in basic science, population science, comparative science, and translational research. Together, the Big Ten CRC supports the work of more than 550 cancer researchers over nearly 40 trials and enrolls more than 1000 patient volunteers in cancer clinical trials. Alongside research, the consortium organizes virtual monthly grand rounds and hosts 2 podcasts, one highlighting the needs of the adolescent and young adult population and the other discussing health equity concerns.

In 2015, the consortium opened its first study to accrual in 80 days and was able to complete enrollment 6 months ahead of schedule. With the support of a strong administrative team and prioritization of Big Ten trials at member institutions, Big Ten studies have an impressive track record of fast timelines. To initiate a study within the Big Ten CRC, investigators first bring their ideas to a disease-specific working group for input from peers on protocol development. The Big Ten CRC administration then assists investigators with letter of intent (LOI) submission, draft budgeting, and other logistics. The goal is to have a study up and running within 12 months of initial funding approval.

To determine which sites will carry out a study, the Big Ten CRC administration conducts a feasibility survey, assessing each site’s needs and interests and ultimately gauges the sites’ ability to prioritize the trial. The strength of the consortium is that it brings together resources from these diverse universities and provides investigators with a much larger platform through which to conduct their trials. Veronika Bachanova, MD, PhD, a hematologist/oncologist at the University of Minnesota, was leading a study that was already sponsor-approved when she brought it to the Big Ten CRC. Because the study was investigating a rare disease, Dr. Bachanova realized that conducting the study through a large consortium would substantially expedite enrollment. In general, multicenter studies can be fraught with complexities, but the Big Ten CRC is set up to handle multicenter studies with great efficiency, resulting in a smoother experience for investigators than if they were to try to coordinate on their own.

One important aspect that sets the Big Ten CRC apart from other consortiums is its emphasis on mentorship. The Big Ten CRC serves as an excellent platform for new investigators to gain experience in developing studies. In the consortium, every study has a coinvestigator who is a junior faculty member. Junior investigators are paired with mentors throughout the various institutions to help develop their research and leadership skills. Each disease-specific working group also rotates its chairs every 2 years, giving junior faculty the opportunity to lead working groups. Monika Joshi, MD, MRCP, chief scientific officer of the Big Ten CRC, started as a junior investigator with the consortium in 2014 and credits the Big Ten CRC for playing a pivotal role in her own professional journey. As a junior investigator on the Big Ten CRC’s first study, Dr. Joshi has gone on to spearhead practice-changing advancements in bladder cancer. The consortium is proud to play a part in shaping the nation’s young investigators into its future leaders in cancer care.

All in all, the Big Ten CRC is a testament to the power of collaboration and mentorship across the country. The key takeaway is the atmosphere of teamwork and support palpable throughout the network. Junior investigators are curious and excited to learn, while senior investigators are open to working together and ready to offer their guidance, creating the ideal environment to promote investigator-initiated research. Now in its 12th year, the Big Ten CRC looks forward to many more of years of being competitors on the field, but collaborators in curing cancer.

The inspiration for the program came from a visit to Louisiana State University (LSU) Health New Orleans in 2023 by James Doroshow, MD, director of the Division of Cancer Treatment & Diagnosis, where he first learned about LSU’s Virtual Research Nurse program, in which study nurses worked remotely to support sites throughout the state with research tasks. The utilization of virtual research nurses solved the problem of not being able to find experienced personnel in remote areas to run clinical trials. Dr. Doroshow speculated that if such a framework could be adapted to a larger scale, it could similarly address many staffing issues at trial sites around the country.

The VCTO kicked off with 6 sites in late 2023/early 2024. All NCI-designated cancer centers and NCI Community Oncology Research Program (NCORP) sites were surveyed to assess their research needs and locations. Those with the greatest needs in rural areas or areas severely lacking in accrual were initially selected to participate. Each site received the assistance of VCTO virtual staff in whatever capacity it needed. For instance, some sites fell behind in data entry, while others struggled to keep up with patient screening. Some sites needed assistance with consenting patients and others required support with regulatory aspects. The VCTO staff, consisting of research nurses and data managers with extensive research experience, have skills in all areas of clinical research and are thus able to tailor their support to the needs of each individual site remotely.

Currently, there are 8 VCTO staff members who work remotely to support sites throughout the country, with the goal of expanding to 12 staff members. Before starting at a site, VCTO staff receive thorough onboarding for all the technical components and spend time building a relationship with each site. Mark Wojtowicz, administrative director, Geisinger Cancer Institute—one of VCTO’s initial sites—commends the VCTO staff for their seamless integration into each site’s culture and workflow. According to Wojtowicz, the collaboration with VCTO has been highly effective thus far, enabling the institution to enroll more patients in its studies and providing stability across several research activities.

At Geisinger, one of the major needs that VCTO has initially facilitated is screening patients for trials. By allowing VCTO to focus on specific tasks (such as screening), providers at Geisinger can focus on monitoring study patients and VCTO staff can become more efficient in their respective tasks (ie, maximizing familiarity with eligibility criteria). Geisinger has also engaged VCTO in patient outreach and recruitment; the institution worked with VCTO on developing a local script to introduce the study and VCTO staff contact patients on behalf of Geisinger’s providers.

An important benefit of this collaboration has been the ability to carry out cancer prevention studies that would otherwise have been overshadowed by more imminent treatment trials, particularly when experiencing research staffing turnover. The FORTE Colorectal Cancer Prevention Trial was one of the first studies that Geisinger and VCTO partnered on. Given the complexity of this study involving stakeholders beyond the world of oncology, Wojtowicz believes that Geisinger’s effort to include rural patients has been enhanced by the collaborative work with the VCTO. Currently, the VCTO is involved in at least 5 cancer prevention trials. Overall, in the last year and a half, the program has serviced 18 different protocols at 20 sites (primary sites and their affiliates) and identified over 500 patients for trials, one-third of whom have enrolled.

Though the VCTO program is off to a solid start, it did not get there without challenges. By far, the biggest challenge has been obtaining access to EHRs at various institutions. Depending on the size of a site, and its licensing contracts with EHR providers or their intermediaries, there are countless administrative and legal hurdles to overcome to attain EHR access for a VCTO staff member who is not employed by the site. Simply put, it is much more complicated than opening a paper chart and transcribing the data. Dr. Doroshow notes that this obstacle presented a substantial learning curve during the implementation of the VCTO program. However, based on their experiences, Dr. Doroshow’s team has created various templates and standard operating procedures (SOPs) on how to best manage the corporate and legal entities involved in EHR access. Moving forward, they are better equipped to address these challenges, although the process can still take a lot of time.

In the next few years, Dr. Doroshow hopes to expand the program’s reach to 30 sites and cover up to 35 protocols, with the addition of 4 staff members. Initially conceived as a pilot project, the VCTO program’s early success shows that virtual clinical research support can greatly benefit sites that lack experienced research personnel. By leveraging virtual research staff to combat staffing shortages, the VCTO can help more patients gain access to clinical trials, especially in underserved areas.

Mary Bird Perkins was established over 50 years ago as a radiation facility created through community philanthropic efforts. Over time, it expanded its cancer care offerings and established an affiliation with the LSU Health Sciences Center in New Orleans, Louisiana. That affiliation ended 3 years ago, and Lin was brought on to lead the center through its next phase of clinical research.

“When the disaffiliation happened, there was an opportunity to take a look around and ask, ‘if we have to rebuild the research program, how do we want it built?’ ” Lin said. The new clinical trials program prioritized expanding options for patients and minimizing friction for providers. Three-fifths of Lin’s time is protected for clinical trials administration, and a dedicated operations team supports streamlined enrollment processes, so the burden doesn’t fall on providers.

At a large academic institution, Lin could expect opening a new clinical trial to take anywhere from several months to a year. Mary Bird Perkins typically completes the process in less than 3 months. Lin recalled a clinical trial that enrolled patients at both his center and a large, NCI-designated academic center a few states away. When the trial added a new experimental arm, Mary Bird Perkins was able to implement that amendment immediately. The larger academic center was much less nimble, caught up by bureaucracy and clunkier approval processes. That center had to refer one of its patients to Mary Bird Perkins to ensure timely care.

Another goal of the center was to increase the participation of minority populations in clinical trials. Mobile screening units and educational outreach have been key to its success so far. Teams of providers travel to community gathering spots, like churches, barbershops, and festivals, in health care deserts across Louisiana. Clinical trial navigators and community outreach staff work in tandem to operate these programs and are integral to running them.

Many of its events include cancer screenings, but all emphasize education about clinical trials. Historical mistreatment of minority groups in clinical trials in the South has led to a lack of trust. Community outreach staff aim to educate individuals on how clinical trials operate, how they benefit participants, and the rights of patients to make their own decisions or unenroll without consequence. Establishing this knowledge early, before an individual is faced with a diagnosis and opportunity to join an experimental trial, helps them to make informed decisions in the future.

Lin described Louisiana as a “clinical trial desert.” The state has some academic centers, but it lacks an NCI-designated cancer center. Mary Bird Perkins recognizes that all patients, regardless of location, deserve options in their cancer care. “[If their] choices are to stay at home and go on hospice, or to leave the state, it’s not a fair choice,” Lin said. He and his team use the clinical trial program as a tool to expand access and give their patients better options.

To solve this problem within its community, the Duke Office of Clinical Research is launching a 1-year apprenticeship program this fall in partnership with Durham Technical Community College (Durham Tech) to train young professionals into a CRC role. Apprentices in this program will graduate with a clinical trials research associate degree from Durham Tech, after which they will be hired as full-time apprentices in a clinical research unit at Duke University. A designated mentor in the unit will guide the apprentice through a prescribed hands-on training regimen to develop key clinical research competencies. Essentially, the apprentice will mirror the role of a CRS at the outset, with increasing responsibility throughout the year, to meet the eventual goal of functioning as an independent CRC by completion of the apprenticeship. Moreover, any full-time employee who has worked at Duke for at least 6 months is eligible for a tuition benefit, allowing apprentices who wish to continue their education to do so at a significantly reduced out-of-pocket cost.

The Duke Office of Clinical Research (DOCR) State-Registered Clinical Research Apprenticeship Program built using the Joint Taskforce for Clinical Trial Competency framework, which Duke has woven into hiring, advancement, and training practices for its workforce for over a decade. Apprentices will build skills in core competencies plus at least 10 additional elective competencies in the following domains: research operations, safety and ethics, data, scientific concepts, site and study management, and leadership and professional development. Trainees will complete competency assessments at 6 months and at the end of the program. The apprenticeship should take 1 year to complete but may run shorter or longer depending on the individual trainee. Once a trainee successfully completes the year-end competencies, they will transition seamlessly into a CRC role with their research team without having to apply for a new job elsewhere. Due to the clinical research–specific degree requirement and directly related on-the-job training, the apprenticeship program accelerates the path to becoming a CRC by 1 year, allowing a student to complete an associate degree and apprenticeship in 3 years.

The apprenticeship program obtained state approval from ApprenticeshipNC in January and will pilot this fall with 2 trainees in the Duke Cancer Institute Oncology Clinical Research Unit. Duke’s program is currently the only state-registered clinical research apprenticeship in North Carolina and the second state-registered clinical research apprenticeship in the US. Stephanie Freel, PhD, PMP, director of clinical research operations, education, and outreach in the Duke Office of Clinical Research, and her team worked closely with Washington University in St Louis to align components of their respective programs. Duke’s apprenticeship program is partially supported by a 5-year grant from Bloomberg Philanthropies, which is seeking to “address critical health care workforce needs while preparing young adults for successful careers in the field” as part of its student-centered, market-driven health care education initiative.

In addition to the apprenticeship program with Durham Tech, the grant also supports a high school program for students at Durham Public Schools who are interested in nursing, allied health, clinical research, and becoming surgical technicians. The Durham Early College of Health Sciences (DECHS) high school opened in August with 104 9th graders. DECHS will allow students to earn both a high school diploma and associate degree during high school. In the first 2 years, students will be able to explore different health care pathways to choose a focus by 11th grade. Then, they will spend the next 2 to 3 years working on certifications, shadowing career professionals, and training in their chosen field. Those in the clinical research pathway have the option to complete their associate degree and a paid preapprenticeship during the 13th grade transitional year, at which point they could be hired into the clinical research apprenticeship directly from high school. In this way, the Durham Tech and early college high school tracks converge into the research apprenticeship program at Duke University.

Dr. Freel believes that a research apprenticeship program in collaboration with local schools has the potential to foster long-term workforce retention due to the intentionality introduced early in a student’s career pursuit. Traditionally, clinical research departments across the globe have experienced difficulties with staff turnover, especially among earlier career professionals for whom this may be their first opportunity to explore career paths. The hope with an apprenticeship program is that it will attract young adults who have deliberately pursued a career in clinical research, allowing for early career exploration and decisions before entering the field.

According to Dr. Freel, implementing a research apprenticeship program is likely feasible for many institutions if it receives sufficient financial support to sustain the model. Ultimately, it is similar to creating a highly structured onboarding program for a new hire. What is most important is that institutions have strong support and buy-in from their principal investigators, clinical research professional mentors, and other partners. An institutional culture open to training and mentorship is the first step toward building an apprenticeship program. For independent sites that are not affiliated with local schools, Dr. Freel suggests looking into the Consortium of Academic Programs in Clinical Research (CoAPCR) for potential partnerships, as well as support resources from the Association of Clinical Research Professionals (ACRP) and the Association of Clinical and Translational Science Clinical Research Professional Taskforce (CRPT) Special Interest Group. Those who are interested in starting a similar program at their institutions may reach out to the Duke Workforce Engagement and Resilience team at wer-jobs@dm.duke.edu for more information.