ACORI Research Review: June 2025

Hybrid Decentralized Clinical Trials (DCTs)

First piloted just over a decade ago, decentralized clinical trials (DCTs) have emerged as a promising strategy to expand participation, particularly among populations with limited access due to geographic or socioeconomic barriers. DCTs integrate technologies and processes not traditionally used in conventional trials to allow for trial-related activities outside of primary trial sites. These may include telemedicine visits, mobile health services, and partnerships with local or community health care providers (HCPs), who can conduct clinical assessments or administer aspects of care.

DCTs can be fully remote or adopt a hybrid model that combines decentralized components—such as at-home visits, e-consent, or care delivered by local HCPs—with traditional trial infrastructure.

The Hybrid DCT Program at University of North Carolina (UNC) Chapel Hill

At the 51st ACCC Annual Meeting and Cancer Center Business Summit (AMCCBS), J. Kaitlin Morrison, PhD, executive director of UNC Lineberger Clinical Research and assistant professor of medicine—hematology at UNC Chapel Hill, spoke about the hybrid DCT model.

Developed in alignment with the 2024 guidance published by the Food and Drug Administration (FDA), the UNC hybrid model distinguishes between trial activities based on their complexity and the expertise required. Tasks demanding extensive knowledge of the investigational product are conducted at UNC’s Lineberger Comprehensive Cancer Center (LCCC), an academic setting. Meanwhile, standard clinical procedures—such as blood draws and defined dose administration, many of which are not considered direct research activities—are delegated to local HCPs or community hospitals where patients typically receive care.

Speaking to ACCC about the motivation behind this model, Dr. Morrison stated, “One of the challenges for the clinical operations team is how to meet patients where they are. North Carolina is a big state that is 550 miles long; for some patients, the journey to care at an academic medical center is an 8-hour round trip.”

The HOPE Bus Tour: Building Community Partnerships

In developing hybrid DCTs, Dr. Morrison; coprimary investigator Dr. Carrie Lee, MD, MPH; and their colleagues recognized that community partnerships needed to extend beyond study logistics. Effective implementation requires sustained, bidirectional communication and coordination between academic institutions and community HCPs to foster mutual understanding and seamless integration across care settings.

To lay the foundation for this collaboration, representatives from UNC Chapel Hill traveled into surrounding communities across North Carolina to discuss what a hybrid DCT model could look like in practice. With support from the UNC Office of Community Outreach and Engagement, this effort evolved into the Hybrid Operations to Promote Equity (HOPE) Bus Tour.

An essential early step in this initiative involved hosting virtual meetings with local HCPs, regional clinics, and community hospitals to introduce the hybrid DCT concept and coordinate in-person visits from the UNC team. These conversations were framed not just to share information, but to listen and learn from the community’s perspectives on research, clinical workflows, and patient needs. Throughout the 8 months of initial outreach and engagement, the UNC Chapel Hill hybrid DCT team met with 120 individuals—including health care facility CEOs, clinical operations team members, HCPs, and patient advocates—across 9 health care systems in North Carolina. The HOPE Bus Tour became a vehicle not only for outreach but for cultivating trust, building relationships, and cocreating a more accessible research infrastructure.

Triumphs and Challenges of a Hybrid DCT Model

Dr. Morrison highlighted the emergence of a statewide clinical research community as one of the program’s most meaningful achievements thus far. She also underscored the invaluable support that local practices provide for their patients, such as free lunches for patients and caregivers during infusion visits, transportation assistance, and complimentary valet parking.

However, overly complex trial protocols can be a barrier to successful implementation of hybrid DCT programs. To minimize complexity, there are several approaches that optimize the design and execution of this model:

• Simplify protocols: Avoid unnecessary complexity and align with standard-of-care practices to reduce ambiguity and improve feasibility.
• Clarify billing and compliance: Understand and plan for billing coverage analyses to prevent delays.
• Develop patient-centered tools: Create educational handouts, treatment calendars, and other resources to support communication and engagement.
• Limit dose modification language: Where possible, rely on FDA-approved labeling and package inserts rather than complex protocol-specific dose adjustments.
• Establish bidirectional communication plans: Ensure mechanisms are in place for patients to report adverse events directly to the study team. Tools such as patient emergency cards can facilitate this process.

Community Partnerships Enable Trial Enrollment—and a Path Forward

Leveraging the hybrid DCT model, the UNC team successfully launched 2 pilot studies within the first year:

• HARMONY: Evaluating whether an RNA-based molecular subtyping assay aligns with clinical subtype classifications and influences treatment decisions in patients with metastatic breast cancer.
• CAMERAN: Comparing the impact of radiation therapy versus endocrine therapy on quality of life and outcomes in low-risk elderly patients with breast cancer.

Both studies were initiated at UNC Health Rex, a longstanding community partner located approximately 40 minutes from LCCC. As of this writing, 23 patients have enrolled across the 2 trials—early evidence of the model’s potential to increase access and facilitate participation outside academic medical centers.

Building on this initial success, Dr. Morrison and her colleagues are expanding the program. Additional partnerships are in development with UNC Rockingham, Pardee, Nash, and Novant-New Hanover, with patient enrollment at these sites expected to begin in summer 2025. These new collaborations mark a significant step forward in creating a more distributed and equitable research network across North Carolina.

The idea for the workshop was initially formed 2 years ago by Reyes and Macias, in response to a call for more in-depth research training following a mandatory research course. At SCI, all APPs are required to take a basic clinical research course, but a number of APPs expressed interest in receiving additional training. Reyes and Macias realized that APPs had the skills to conduct research but did not know how to operationalize the process or integrate it into their busy workdays. They spent significant time brainstorming how to make research more accessible for APPs and oncology research nurses while still maintaining their strong presence in the clinic.

The result was the Investigator & Oncology Research Nurse Professional (ORNP) Skills Workshop—a full-day, in-person program focused on building practical skills for conducting clinical trials. Workshop objectives include:

• Using documentation to support billable, equitable trial screening practices that reduce barriers to enrollment
• Improving patient safety and the eligibility process through clear, accurate source documentation
• Developing standard operating research practices to enhance data integrity and workflows
• Promoting collaborative partnerships between faculty, clinicians, and research staff
• Advancing health equity and diversity in clinical trials while acknowledging implicit biases
• Understanding how SCI Clinical Trials Office operational and quality groups can support ORNPs and investigators

The workshop blends didactic instruction with small-group sessions that follow a patient’s full journey through a clinical trial. Didactic topics include:

• Cancer clinical research at SCI: organization, roles, language
• Research budget and billingCollaborative relationships: leadership and communication
• Best practices: screening and billing for trial counseling
• Best practices: screening and eligibility
• Meet the patient: identify and overcome barriers

Diversity, equity, and inclusion principles are integrated throughout the day to promote equitable access to research and care.

In the afternoon, participants break into small groups to review how to navigate protocols, consent patients, evaluate screening and eligibility criteria, assess for adverse events and dose modifications, and manage end-of-treatment procedures and follow-up visits. For these small-group sessions, each participant brings an active protocol from their own practice, creating a dynamic, hands-on learning experience that highlights variability and complexity across different clinical trials and settings. In addition to practical skills, the workshop equips participants with best practices to help streamline trial operations in their daily workflow. For example, one best practice is to convert a trial’s eligibility criteria into an automated clinical documentation list in the electronic health record (EHR) so that providers can easily identify potential barriers to participation when meeting with a patient. In the workshop, APPs work on creating these eligibility criteria smart phrases and can bring them back to their respective clinics. At the end of the workshop, practitioners come together as a group to review takeaways from each session and apply the topics to their personal experiences with a particular trial or patient.

Overall, the workshop has served as an invaluable resource for the APPs and research nurses who have taken this extra step at the institution. Participants gain familiarity with research protocols and, more importantly, begin to build a supportive community with other research-oriented providers. According to Reyes and Macias, this sense of connection is the primary goal of the workshop. The APPs and research professionals who lead the sessions become mentors, and participants can collaborate with one another well beyond the workshop end.

This training would not be possible without the dedication and willingness of the APP and CRC/ORNP mentors at SCI who help run the sessions on a voluntary basis. For other institutions that are looking to implement similar programs, it needs to start with a strong passion to help APPs and nurses expand their clinical research skills. From there, institutional support is critical for establishing the workshop (eg, arranging staffing to allow interested APPs and nurses to attend the session). Moreover, principal investigators have an important role in nurturing the growth and development of APPs in clinical research long after the workshop is over by giving them opportunities to participate in research.

Lastly, the success of the workshop has hinged on strong collaboration between Stanford Health Care’s hospital and university arms—an often-overlooked but essential partnership. With a background in education and behavioral neuroscience, Macias drew on her dual experience as a trial coordinator and educator to help shape a curriculum that bridges both institutional cultures. While many cancer centers collaborate across the hospital and university spaces in research and clinical care, education remains a less integrated space—making this program unique.

With early momentum and promising outcomes, the ORNP Skills Workshop is well-positioned to transform how APPs and oncology research nurses are trained—at Stanford and, potentially, across the broader oncology community.

The lack of trial diversity in myeloma research is a persistent and well-documented issue. The problem was spotlighted in 2018 when investigative reporting by ProPublica and STAT drew attention to the stark underrepresentation of Black patients in pivotal cancer trials. One notable example involved a trial supporting a 2015 FDA approval, in which only 13 out of 722 participants were Black, accounting for just 1.8% of the study population. Given that Black Americans account for about 20% of multiple myeloma cases in the US, this disparity highlights the continued need for more inclusive clinical research that better reflects the diverse population affected by the disease.

In 2017, FDA officials published an article in the journal Blood, noting that Black patients may experience multiple myeloma differently, with variations in symptom presentation, disease progression, and treatment response. The agency emphasized that enrollment of more Black subjects in clinical trials would yield multiple benefits, including more accurate assessments of treatment safety and efficacy across diverse patient populations.

A promising example of change is the SubQSA trial, led by Sanofi, which is evaluating the subcutaneous delivery of isatuximab, an anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma. Using an on-body delivery system, the trial assesses the efficacy, safety, and pharmacokinetics of this new formulation. While the clinical objectives are important, the most innovative aspect of the SubQSA trial lies in its operational design. Departing from the traditional model of relying on large academic medical centers, Sanofi has partnered with community cancer centers that are often more accessible to underserved populations. Setting an ambitious enrollment target of 24% Black patients, the SubQSA trial aims to far exceed the typical representation seen in oncology research. “As pharma companies we…have to be committed to [representative research] because it is the right thing to do,” explained Pamela Brill, RN, MSN, CPNP, field scientific director of hematologic malignancies at Sanofi.

To turn this vision into reality, Sanofi has realigned its medical affairs strategy around equity principles, deploying a multipronged approach that tackles common barriers to participation from multiple angles. Among the most impactful features of the SubQSA trial’s inclusive approach are the following:

• Strategic inclusion/exclusion criteria: Recognizing that many Black patients with multiple myeloma are diagnosed in the setting of renal insufficiency, the trial reduced the standard glomerular filtration rate (GFR) threshold to broaden eligibility. Criteria were also modified to account for benign ethnic neutropenia, a condition more common in individuals of African descent, in which lower absolute neutrophil counts (ANC)—often below 1500—are a normal variant rather than a sign of immunosuppression. Neutrophils are a key component of the immune response, and while low counts can raise safety concerns in trials, this physiologic variation does not typically increase infection risk. The trial also reconsidered exclusion criteria around certain chronic conditions, reflecting a more nuanced approach to eligibility. As Brill noted, “If you have controlled HIV with an undetectable viral load, why can’t you be in the trial?” 
• Flexible pharmacokinetics protocol: Acknowledging that drug metabolism can vary across racial groups, the trial features an optional pharmacokinetics component, as this can have important implications for optimal dosing and toxicity management. To ease the burden of frequent blood draws, Sanofi offers home health nursing support for patients facing geographic barriers or limitations in time and resources. By addressing these common logistical challenges, the trial is helping to make participation more accessible to a broader range of patients. 
• Community site partnerships: Rather than leaning on traditional partnerships with academic centers, Sanofi has intentionally connected with community cancer centers, which currently make up over 50% of active trial sites. A collaboration with Inato has also been helpful; the organization facilitates community site participation by streamlining administrative processes, including regulatory document collection and site communications. This partnership has expedited study start-up timelines and added 2 new community sites that have not previously partnered with the company. Inato’s user-friendly portal has further supported efficient site engagement. 
• Community engagement through M-POWER: With the mission of raising awareness about multiple myeloma in Black communities, the International Myeloma Foundation launched the M-POWER initiative. M-POWER is a “national and local movement, fighting city by city through music, art, barbershops, food trucks, and churches.” By offering educational programs and culturally tailored outreach, M-POWER works to build relationships and trust in the Black community well before trial enrollment begins, helping to address longstanding barriers to participation. Celebrity partners, such as actor and artist Ice-T, along with patient ambassadors who share their trial experiences, are further strengthening community connections and highlighting the personal benefits of trial participation — including increased medical monitoring, attentive care, and the meaningful opportunity to contribute to research that serves the broader community.

By thoughtfully embedding inclusive practices throughout trial design and execution, the SubQSA study is raising the standard for representation in myeloma research. These efforts not only confront historical inequities but also ensure that new therapies are validated across the full spectrum of patients impacted by the disease. As awareness grows and momentum builds, the oncology community faces both an opportunity and a responsibility: to break down barriers that have excluded too many for too long. These efforts reflect a growing recognition that representation in trials is not optional, but essential to delivering on the promise of precision medicine for all patients.

 

 RTFCCR places particular emphasis on the following areas:

• Therapy optimization: Treatment de-escalation, geriatric and pediatric oncology, drug repurposing, and strategies to overcome resistance
• Disease and treatment burden: Supportive care interventions and personalized medicine to reduce symptom load and improve quality of life
• Implementation research: Understanding how and whether evidence-based interventions are adopted in real-world clinical practice
• Early detection and prevention: Innovative methods to identify early cancer or precancerous changes and prevent progression to advanced disease
• Global equity in research: Expanding access to high-quality cancer research in underserved regions, particularly in sub-Saharan Africa.

Central to RTFCCR’s mission is the integration of the patient voice at every stage of research. All funding applications must include a Patient Partner Involvement in Research Plan, ensuring meaningful patient engagement in the design, conduct, and dissemination of research. Each proposal is reviewed for scientific merit and patient relevance, with at least one patient evaluator who has lived experience with the cancer type being studied.

Highlights From ACCC Member Institutions

Currently, RTFCCR supports 48 active grants across 11 countries, several of which have been awarded to ACCC member institutions. Three notable examples are as follows:

• Abhijit Patel, MD, PhD, Yale School of Medicine
  In 2023,  Dr. Patel received a 2-year grant to advance early detection of lung cancer using a predictive model measuring DNA hypermethylation—a marker that becomes evident even when tumor-specific DNA mutations are difficult to detect due to the small size of early-stage tumors. His team is also developing an algorithm to monitor longitudinal DNA changes, which may improve the sensitivity of screening tools for early lung cancer.
• Todd Fehniger, MD, PhD, Washington University in St Louis
  Dr. Fehniger’s group is focused on therapy optimization using memory-like natural killer (ML NK) cells with enhanced antileukemia activity. In a small clinical study involving relapsed patients posthematopoietic cell transplantation (HCT), ML NK cells led to complete remission in 4 of 8 patients—with 2 remissions lasting over 3 months and another remission extending beyond 2 years. His current trial, supported by RTFCCR, combines ML NK cell therapy with haploidentical HCT in pediatric and young adult patients (≤ 30 years) with high-risk AML. The treatment regimen includes conditioning, ML NK cell infusion, and IL-2 to support cell expansion, with the goal of achieving durable remissions and altering the trajectory of relapsed disease in this population. Dr. Fehniger’s team is also exploring the use of ML NK cells in metastatic melanoma resistant to standard immunotherapies. Compared to T cell-based approaches, NK cells may offer a safer, faster alternative for targeting tumors that escape T-cell detection.
• Madhav Dhodapkar, MBBS, Emory University
  Dr. Dhodapkar’s study investigates the relationship between the gut microbiome and development of monoclonal gammopathy of uncertain significance (MGUS). It is thought that certain bacterial species may play a role in the chronic activation of myeloma-encoded B cell receptors, prompting the question of whether antibacterial treatments can impact immunoglobulin levels in patients with MGUS, and potentially serve as a strategy to prevent myeloma.

Funding Opportunities

RTFCCR supports 3 types of funding opportunities: early career grants in supportive care, open call applications, and preapplication grants to support patient partners in their involvement in protocol development. For more information about the grant application process, clinicians can visit the foundation’s webpage.

A Patient-Centric Mission

Founded in 2002 by Roger E. Magowitz in honor of his mother, Seena Magowitz, who passed away from pancreatic cancer in 2001, the Seena Magowitz Foundation (SMF) is dedicated to raising awareness, empowering patients, and funding innovative research. The foundation focuses on 2 primary domains: supporting patients and their families, and advancing clinical research through awarding grants to promising scientific endeavors.

Empowering and Connecting Patients and Families

A pancreatic cancer diagnosis often brings with it complex and urgent needs—not only for patients, but also for caregivers together navigating dietary restrictions, pancreatic exocrine insufficiency, and the emotional toll of the disease’s often late stage at diagnosis.

To meet these needs, the SMF has supported more than 400 patients and survivors through programs tailored to provide emotional and practical assistance. One such initiative is Pancreatic Cancer SOS (Support for Survivorship)—a virtual community that hosts 5 meetings per month for patients and caregivers to connect, share their experiences, and occasionally hear from expert guest speakers. This program fosters community-building and provides an outlet for peer-to-peer support. The meeting schedule is available here.

Another signature program, Second Opinions, helps patients and families access expert guidance from leading pancreatic cancer specialists. Unlike a simple referral, this program offers personalized support throughout the consultation, equipping patients with the information needed to make confident, informed treatment decisions that consider their unique circumstances.

Advancing Pancreatic Cancer Research and Clinical Trials

The SMF is a leading funder of groundbreaking pancreatic cancer research, collaborating with institutions such as the Medical College of Wisconsin (MCW)  and HonorHealth Research Institute. SMF-supported projects typically begin at the $1 million funding level and have contributed to several therapeutic advancements, some of which have become integrated into pancreatic cancer clinical practice guidelines, such as those published by the National Comprehensive Cancer Network (NCCN). Key examples of these successes include:

• Gemcitabine and Abraxane Combination Therapy: An SMF-funded pilot study helped generate the evidence base for the landmark phase 3 MPACT trial, which ultimately established the gemcitabine-abraxane combination as a standard first-line treatment for advanced pancreatic cancer.
• PROTECT-PANC (NCT06228599): This prospective, open-label interventional study evaluates the safety and efficacy of biomarker-guided matched therapies in postsurgical patients with pancreatic cancer at high risk of recurrence. Molecular profiling is used to identify actionable alterations, with treatment decisions informed by a multidisciplinary molecular tumor board.
• PANCREAS Study (NCT04683315): Aiming to characterize tumor subtype—classical or basal—this study is helping guide neoadjuvant treatment strategies for patients with resectable or borderline resectable disease. Early subtype identification at diagnosis may improve personalized treatment planning.

Highlighting Pancreatic Cancer Warriors

The SMF website features compelling first-person accounts from patients, respectfully referred to as “Warriors,” who have navigated the pancreatic cancer journey. These stories—searchable by stage at diagnosis, age, surgical status, trial participation, and years of survivorship—offer valuable insights and hope to newly diagnosed individuals and their families. In addition to patient stories, the SMF also celebrates other warriors, including caregivers, patient advocates, and clinicians whose contributions to research, care, and support are helping to change the narrative around this formidable disease.

Advancing Navigation Training and Resources

A national leader in oncology patient navigation, Dr. Pratt-Chapman spearheaded the development of consensus-based core competencies for oncology navigators and launched a free training program to equip professionals with essential skills. On March 19, 2025, she relaunched the updated Oncology Patient Navigator Training—originally introduced in 2015—which saw over 1000 learners enroll in its first month. More than 12,000 learners from 42 countries have accessed her initial Oncology Patient Navigation Training: The Fundamentals. This remains the only known free training that meets Centers for Medicare & Medicaid Services requirements for principal illness navigation (PIN) billing. The program now includes updated guides and downloadable slide decks available on the GW Cancer Center’s Resources page. The impact of the training extends beyond individual learners, equipping institutions with essential tools to improve continuity of care, patient communication, and navigation services—especially for underserved communities.

 

Tackling Disparities in Cancer Care for LGBTQ+ Patients

In January 2025, her commentary titled “Mental Health Disparities Among LGBTQ People in the US—Time to End the Stigma” was published in JAMA Network Open, highlighting the urgent need to address systemic bias and stigma affecting LGBTQ+ populations.

She has also worked with colleagues over the last 4 years to refine how providers and researchers ask patients and participants about sexual orientation and gender identity. Dr. Pratt-Chapman was coprincipal investigator for the National Cancer Survivorship Resource Center and coauthored 4 holistic clinical practice guidelines on breast, prostate, colorectal, and head and neck cancer survivorship care.

She is in her 12th year of continuous funding from the Centers for Disease Control and Prevention to provide technical assistance and training on evidence-based cancer control strategies and health equity to states, tribes, and territories across the US.

As she accepted her award, Dr. Pratt-Chapman emphasized the importance of practical application: “We’ve always focused on application: How do we make what we learn available and usable for practices and for patients?” She also highlighted the recent opening of the GW cancer prevention and wellness center in Ward 8 in Washington, DC, “which is closer to...the people who often have to travel the furthest for cancer treatment.”

Commitment to Advocacy and Collective Action

Dr. Pratt-Chapman also underscored the importance of advocacy, urging, “Silence isn’t neutral. [Advocacy] doesn’t mean that you have to be loud or put yourself at risk, but that you’re standing up for the people around you and protecting them.” Despite the challenges, Dr. Pratt-Chapman remains steadfast, saying, “It’s going to take all of us. I’m extremely honored to accept this award.”

Named in memory of David K. King, MD, FACP—a past ACCC president who dedicated his life to caring for individuals with cancer—this award pays tribute to his enduring legacy. Dr. King was a tireless advocate for equitable access to quality cancer care and a champion of community-based research through the Community Clinical Oncology Program.

 

Celebrating Dr. J. Thaddeus Beck’s Contributions

A tireless champion of clinical research in the community setting, Beck has been instrumental in bringing cutting-edge trials—including phase I studies—to patients in Arkansas. Through his leadership, Highlands Oncology has become a hub for innovative cancer care, offering early access to promising therapies for individuals in geographically underserved areas. By establishing and expanding a robust clinical trials program, Dr. Beck has helped bridge the gap between academic research and community oncology, ensuring that patients do not need to travel far to receive advanced treatments.

Building a Model for Community-Based Research

“In 2025 we now have 50 open trials and 50 employees,” Dr. Beck noted. His sustained commitment to building a thriving community-based research structure has elevated the quality of care for patients with cancer and increased access to clinical trials in the region. For other organizations looking to develop a successful research environment, he recommends appointing an engaged, dedicated physician leader. By having great partners and providing dedicated time for that staff member, there will be a greater chance of successful trial operationalization.

Dr. Beck has long emphasized that to move the needle for cancer research at the national level, it is critical to empower community cancer centers to conduct clinical trials on-site. In a 2021 Oncology Issues article, he explained: “If you want to double or triple national enrollments, you have to have community participation, especially in phase I trials where the visits might be daily for a week and weekly for a month.”

Mentorship, Innovation, and Advocacy

Dr. Beck’s impact extends beyond clinical trials—he has become a mentor and role model for other oncology professionals seeking to bring research into the community setting. His leadership at Highlands Oncology has fostered a culture of innovation, where collaboration between oncologists, nurses, and research staff enables efficient and effective trial implementation.

By fostering partnerships with academic institutions and pharmaceutical sponsors, Dr. Beck has ensured that community-based programs like Highlands Oncology remain at the forefront of clinical research. He continues to advocate for increased support, resources, and funding to help community cancer programs realize their full potential as vital contributors to the national research landscape.

A Lasting Impact on Oncology Care

Dr. Beck’s leadership has led to meaningful advances in clinical trial access and in the development of new screening, risk assessment, treatment, and supportive care programs designed to meet the needs of patients in community settings. Reflecting on the recognition, Dr. Beck said, “I am humbled and honored to receive this award from ACCC.” Dr. Beck’s efforts have expanded access to clinical trials and high-quality care in his community, providing a practical example for other institutions aiming to do the same.