The oncology clinical research landscape is undergoing trans- formative changes, marked by patient-centered approaches and operational efficiency in the community setting. New strategies for clinical trial design seek to ensure that study populations reflect the true heterogeneity of all patients affected by cancer, thereby improving the generalizability and application of clinical research findings. This approach intends to maximize the ability of historically underrepresented individuals (eg, racial and ethnic minorities, older adults, rural residents, and those with comorbid conditions) to overcome barriers to participation in clinical trials.

On October 29-30, 2024, the Association of Cancer Care Centers (ACCC) Community Oncology Research Institute (ACORI) hosted the Community Oncology Inclusive Clinical Trial Design Summit in Arlington, VA. The summit brought together key stakeholders, including academic and community cancer center practitioners and researchers, advocacy organizations, government agencies, and industry partners in oncology patient care and clinical research to discuss ways to collaboratively and strategically reduce barriers to clinical trial participation.

Representative clinical trial design has the potential to maximize scientific rigor and identify subgroup-specific responses to treatments, contributing to more personalized cancer care. Expanding the clinical trial workforce and leveraging AI technology can help address logistical challenges and build the capacity of com- munity cancer centers to participate in clinical research. Broader eligibility criteria can enable participation by patients with many different characteristics, while community-based trial sites and decentralized trial designs can help bridge gaps in access, particularly in underserved geographical regions. By meeting systemic challenges with innovative solutions, oncology clinical research can continue to deliver meaningful improvements in cancer care and patient outcomes.

Strengthen the clinical trial workforce

The current clinical trial workforce is facing a critical shortage that threatens the ability to advance oncology research to its fullest potential. A growing demand for clinical trials, driven by numerous preclinical successes and a surge in precision medicine initiatives, has outpaced the capacity of the existing workforce. This shortage not only delays trial initiation and completion but also hinders efforts to meet regulatory requirements, ensure data quality, and maintain patient safety.

Advanced practice providers (APPs), including nurse practitioners (NPs) and physician assistants (PAs), in addition to clinical pharmacists (PharmDs), are continuously on the frontlines of day-to-day oncology care delivery. Despite their extensive expertise, their potential in oncology clinical research remains underuti lized. These professionals offer a wealth of knowledge in patient care, medication management, and adverse event mitigation— critical components of clinical trial success. A 2020 survey of more than 400 oncology APPs revealed that more than 90% believe they should be more involved in clinical research.1 Similarly, PharmDs are uniquely equipped to contribute as investigators, given their specialized training in pharmacology and protocol adherence, yet their involvement as principal investigators (PIs) remains limited.

Additionally, there is a continuing shortage of clinical research coordinators (CRCs) leading to a lack of support for clinical trial implementation at the institutional level. The administrative and operational capacity necessary to successfully facilitate clinical trials is often lacking in the community setting. This challenge is further compounded by the increasing complexity of trial proto- cols, which require greater administrative oversight and multi- disciplinary collaboration. Without targeted efforts to expand and support the clinical research workforce, the gap between trial demand and execution will continue to widen, ultimately limiting patient access to innovative therapies and slowing the progress of oncology research.

Strategic Actions

Hold consensus-building events to raise awareness:

It is necessary to increase awareness among clinical trial sponsors and health care institutions (and even among APPs and clinical pharmacists themselves) about the contributions these professionals can make to clinical research. Many institutions are unaware that the National Cancer Institute (NCI) now permits APPs to sign clinical trial treatment orders. As such, APPs should be encouraged to practice at the top of their license, including providing care to and recruitment of patients for clinical trials. Moreover, highlighting successful instances of APPs and PharmDs serving as PIs can provide powerful examples to institutional decision makers. Holding events such as town halls, grand rounds, or conference workshops can help to empower these individuals and connect them with the resources needed to make a difference. A summary of the event’s discussion and findings could be released to the public to further expand awareness and inspire APPs and PharmDs looking to get involved with clinical research.

Advocate for institutional support:

Advocacy for policy changes at the institutional level is necessary to expand the roles of APPs and PharmDs in clinical research within each organization. Measuring the financial and clinical value of these individuals in the PI and sub-PI roles can make the business case to administrators by demonstrating the expected return on investment (ROI). Research cooperative groups with high participation rates of APPs/PharmDs as PIs should showcase their results and share expertise/best practices.

Standardize training programs and networking:

Establishing foundational, widely recognized educational initiatives is essential for the successful integration of APPs and PharmDs into clinical research leadership. Events such as a “clinical trial bootcamp” can equip these professionals with the need-to-know information to enter clinical research, and ongoing competency-based training can help to solidify knowledge as they grow into the role. Bootcamp events can be leveraged to develop a robust national network of emerging PIs, facilitating the exchange of best practices, fostering collaboration, and providing critical mentorship opportunities to more research-oriented PharmDs and APPs looking to segue into clinical research leadership.

Employ clinical trial navigators:

The time burden required to meet administrative and operational demands can be significant, particularly in resource- limited settings. Clinical trial navigators can serve as a vital link between patients, health care providers, and research teams, addressing barriers to clinical trial participation and alleviating the administrative burden on clinical staff and investigators. Clinical trial navigators educate patients about the purpose, benefits, and risks of clinical trials, dispel misconceptions, and help match eligible patients to appropriate studies. Employing clinical trial navigators early in the process is crucial, as their proactive involvement helps identify potential barriers and ensures smoother patient enrollment, engagement, and retention throughout the study. By coordinating logistical aspects such as scheduling, transportation, and insurance inquiries, navigators reduce barriers to enrollment while providing consistent support throughout the trial to improve retention and adherence.

Address clinical research coordinator (CRC) shortage:

A multifaceted approach to improving the CRC shortage could include allowing flexible qualification criteria and emphasizing transferable skills from public health, administration, and data management fields. Providing clear career progression pathways and certification opportunities [eg, through the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA)] may foster long-term engagement. Lastly, easily accessible educational programs are needed to train aspiring CRCs.

Support strategic training programs:

Educational initiatives highlighting careers in research should be designed for high school and college students with the goals of building a future workforce reflective of the communities where they work and improving public awareness about the role of clinical trials in oncology. Training an expansive clinical trial workforce is important, especially as racially representative investigators have been demonstrated to encourage clinical trial enrollment of racially concordant study participants.

Leverage AI and digital tools*:

Platforms such as clinical trial management systems (CTMS) and electronic data capture (EDC) can help to reduce administrative burden. EDC tools allow for real- time data collection and integration across multiple physical locations, reducing errors and delays in data reporting.

Natural language processing (NLP) can extract relevant information from unstructured data sources such as clinical notes or patient-reported outcomes (PROs).

Automating tasks such as scheduling visits, sending reminders, and generating data reports could allow PIs, CRCs, and clinical trial navigators to focus on other core responsibilities and improve work-life balance, which could drive staff retention.

*For each topic, summit attendees identified ways that AI and digital tools could benefit strategic action. This theme is highlighted throughout this article.

Meaningfully expanding the clinical trial workforce to meet the demands of clinical research in the community setting will require leadership that understands the needs of the communities they hope to serve. Leveraging clinical trial navigators, digital technology, and addressing the CRC shortage can all contribute toward this goal. Through institutional support, consensus building, targeted education programs, and networking/mentorship opportunities, the clinical trial workforce can be expanded to support community oncology clinical trials, thereby diversifying trial participation and improving the quality of evidence generated.

Resources

Advanced Practice Provider (APP) Clinical Trials Research Manual | ECOG-ACRIN Cancer Research Group | “How to” manual for APPs interested in oncology clinical research

*login required

Virtual Advanced Practice Provider (APP) Clinical Research Workshop | Southwest Oncology Group (SWOG) | Clinical trial educational resources, including a series of 7 online modules with the option for 3 continuing medical education credits

Defining the Role of the Advanced Practice Provider Within the National Cancer Institute Community Oncology Research Program (NCORP) | JCO Oncology Practice | A 2022 survey of 271 cancer practices about the role of APPs in clinical research

Investigator Racial Diversity and Clinical Trial Participation

| Journal of Health Economics | Concordance between investigator and study participant background promoted trial participation

Optimize trial design to reflect real-world patient populations

The evidence generated by oncology clinical research should be broadly applicable, representing the true mix of all patients with cancer. Traditional trial design tends to select homogenous, affluent patient populations that lack comorbid conditions frequently seen in daily clinical practice.2 Efforts to redesign cancer clinical trials must account for real-world patient demographics, integrate representative study participants, and tackle systemic barriers that prevent participation from underrepresented and marginalized groups.

Historically, restrictive inclusion and exclusion criteria have led to negative externalities: trial participation can be severely limited, and study results subsequently lack external validity. Traditional trial design often relies on stringent eligibility criteria, such as age, performance status, and absence of comorbidities, which ultimately excludes a substantial proportion of patients seen in real-world clinical practice. These strict criteria stem from a focus on tightly controlled environments to reduce variability, but this practice inadvertently limits the generalizability of findings. Additionally, restrictive eligibility criteria can perpetuate imbalances in clinical research participation, as these exclusions disproportionately affect populations such as older adults, individuals from racial and ethnic minority groups, those with socioeconomic challenges, and patients with comorbid chronic illnesses, leading to a lack of data on how novel therapeutics perform in these heterogeneous groups

Strategic Actions

Promote pragmatic clinical trials:

Unlike traditional research studies, pragmatic clinical trials are designed to evaluate the effectiveness of interventions in real-world settings rather than idealized or highly controlled conditions. Pragmatic clinical trials prioritize generalizability and practical applicability to everyday clinical practice with priorities that include minimal disruption to routine care. This approach both improves the feasibility of conducting the trial (particularly in the community setting) and captures the myriad of factors that impact real-life patients. Another priority is measuring outcomes of interest to patients, clinicians, and policymakers, such as quality of life, symptom management, and cost-effectiveness.

Reassess and redesign eligibility criteria:

An appraisal of inclusion/exclusion criteria should aim to minimize overly restrictive criteria, with an emphasis on providing scientific justification for each exclusion criterion. Utilizing real- world data, such as electronic health records (EHRs) and patient registries could provide critical insights into reasonable standards for eligibility that reflect the true characteristics of patients with cancer. For example, trials could adapt criteria to include patients with controlled chronic conditions that have been traditionally excluded, thereby ensuring broader applicability of trial results.

Simplify protocols:

Complex trial protocols often create barriers for both patients and health care providers. Simplified assessments (eg, reducing the frequency or invasiveness of required procedures and testing) can reduce the burden of participation placed on patients. Incorporating local standard-of-care control arms allows for a more pragmatic approach while maintaining scientific rigor. Patient-friendly practices such as electronic consent (e-consent) forms and multilingual validation of PROs are both important tools for maximizing accessibility and retention of study participants.

Engage community providers early in the design process:

Collaborating with local health care providers early in the trial design process allows research staff to consider their feedback before proceeding. Providers who are familiar with their community’s health challenges can offer valuable insights into potential barriers and solutions before roadblocks are encountered once the trial has already become active. Local primary care providers can serve as sub-investigators or co-investigators and can assist with clinical trial activities such as data collection or monitoring for adverse events.

Leverage AI and digital tools*:

Using machine learning models at the trial design stage can optimize protocols by analyzing historical trial data, ensuring feasibility and minimizing logistical hurdles.

AI-driven patient matching is also possible by analyzing EHRs to identify patients who meet eligibility criteria, significantly reducing the manual effort traditionally necessary for recruitment.

Lastly, regulatory oversight can be facilitated using tools that ensure operations adhere to guidelines and flag potential noncompliance issues early during the planning stage.

Optimizing trial design to better reflect real-world patient populations is essential for ensuring that oncology research findings are broadly applicable. Thoughtful eligibility criteria can broaden trial participation, aligning research protocols with patient realities. Engaging community providers early in the design process and leveraging AI-driven tools can enhance representative recruitment, streamline trial operations, and improve oversight, especially in community oncology clinical research. By redesigning trials with representative clinical research at the forefront, clinical trials can generate more meaningful and representative data, improve trial relevance to the communities included, and maximize health care outcomes for all patients with cancer

Resources

NIH Clinical Research Trials and You | National Institutes of Health (NIH) | Educational resources and information about diversity in research

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement | American Society of Clinical Oncology (ASCO) & Association of Cancer Care Centers (ACCC) | Recommendations and strategies for the research commu- nity to improve representation in cancer clinical trials

Advancing Equity in Cancer Research: Opportunities for Sponsors, Institutions, and Investigators | North Carolina Medical Journal | Strategies for industry and academia

The Clinical Research Investigator: Clarifying the Misconceptions

Engage with communities outside of clinical trial interactions

Successful community engagement in clinical trials extends beyond recruitment efforts and requires ongoing, bidirectional communication between researchers and the populations they aim to serve. A 2023 study analyzed data from the Health Information National Trends Survey (HINTS) and observed that when individuals have prior knowledge of clinical trials, they are more likely to trust health care organizations. Conversely, the absence of robust community engagement and patient education can create a cascade of problems for cancer clinical trials in the community, from recruitment challenges to delayed trial timelines and missed opportunities for patient-centered research. Proactively engaging with communities and individual patients (before and after diagnosis) through education, outreach programs, and partnerships with trusted local organizations is essential for building trust, overcoming barriers, and ensuring trials are accessible to all patients with cancer.

Strategic Actions

Engage with communities prior to diagnosis:

Educating patients about clinical trials before a diagnosis reduces the cognitive burden when decisions are time-sensitive. Preemptive education fosters informed, shared decision-making. Building conversations about clinical trials into primary care workflows can help introduce the clinical trial concept in a less emotionally driven setting. On a larger scale, using tailored campaigns (such as those focused on high-risk populations) can ensure early awareness of clinical trials for relevant cancers, improving participation in prevention and screening trials in addition to therapeutic trials.

Interact with community/patient stakeholders early and often:

Collaboration with organizations such as rural health associations, LGBTQIA+ networks, and patient advocacy groups can inform representative trial design. Including patients and/or patient representatives on cancer care teams and during trial protocol development can ensure that trials consider the needs and experiences of different patient populations. Resources that guide community engagement efforts, such as templates for negotiating budgets with sponsors and best practices for outreach, can help organizations strengthen ties with local populations. Lastly, cancer-specific community ambassador programs should be created that are modeled after historically successful initiatives such as the Centers for Disease Control and Prevention (CDC) HIV community ambassador program.

Address systemic barriers:

It is important that the individuals comprising clinical trial staff and leadership teams are representative of the communities they serve, as patients are more likely to trust and engage with research teams that reflect their own backgrounds and lived experiences. To support this goal, resources should be allocated to facilitate nontraditional recruitment efforts such as targeted advertisements on social media platforms and outreach through community-based organizations that already have established relationships with underrepresented patient populations. Incorporating social drivers of health (SDOH) and peer support into trial frameworks can help address the logistical, financial, and cultural barriers that often deter participation. However, these efforts must extend beyond individual trials. Long-term strategic action plans at the institutional level (independent of specific trials or sponsors) will be essential to ensure sustainable progress.

Enhance representation through accountability:

Establishing benchmarks and accountability measures in trial guidelines can ensure representation goals are met and avoid unintended exclusions. Studying and addressing historical and systemic barriers can build trust with different communities and create accessible participation pathways. Efforts to understand the specific needs of hard-to-reach groups can create the opportunity for dialogue that will increase representation in clinical trials.

Address unconscious biases:

Implicit biases can significantly influence how PIs and research staff approach patient screening, recruitment, and selection, often leading to inadvertent exclusion of underrepresented populations. Biases may manifest as assumptions about a patient’s willingness or ability to participate in clinical trials, perceived adherence to protocols, or misconceptions of cultural and socioeconomic factors. Structured training programs, such as the Just Ask™

Increasing Diversity in Cancer Clinical Research initiative, should be utilized to address implicit bias issues in clinical trial recruitment. Additionally, integrating standardized screening tools and decision-support algorithms can help reduce human subjectivity in patient selection.

Leverage AI and digital tools*:

Chatbots, email campaigns, and social media platforms powered by AI can engage potential study participants and provide tailored information about trial opportunities specific to local communities. “Gamification” and engagement platforms can increase retention and adherence by offering incentives, tracking progress transparently, and offering interactive content to study participants and caregivers. AI-powered EHR add-ons can help objectively identify patients for trials while reducing PI subjectivity.

Resources

Just ASK™ Increasing Diversity in Cancer Clinical Research | ACCC-ASCO | Approximately 4-hour virtual implicit bias training program for cancer clinical research professionals

An Assessment of the Feasibility and Utility of an ACCC-ASCO Implicit Bias Training Program to Enhance Racial and Ethnic Diversity in Cancer Clinical Trials | JCO Oncology Practice | Pilot study of the Just ASKTM program implemented in 50 cancer programs nationwide

Research Ambassador Program: An Innovative Educational Approach to Addressing Underrepresentation of Minority Populations in Clinical Research | Journal of Clinical and Translational Science | Interactive educational workshop delivered by community health workers to address common myths, fears, and concerns about clinical research

A Narrative Review of Rural Community Engagement Strategies

| Journal of Clinical and Translational Science | Review of how community engagement contributed to clinical research success, especially for recruitment, participation, building trust, and partnership

Contributions of Community-Based Organizations Funded by the Centers for Disease Control and Prevention’s HIV Testing Program

| Centers for Disease Control and Prevention (CDC) | An analysis of National HIV Prevention Program Monitoring and Evaluation HIV testing data submitted between 2012 and 2017 to CDC

What Influences Trust In And Understanding Of Clinical Trials? An Analysis Of Information And Communication Technology Use And Online Health Behavior From The Health Information National Trends Survey | University of Kentucky | A 2023 analysis of factors influencing trust and comprehension of clinical trial information

Expand research access through decentralized clinical trials (DCTs)

Decentralized clinical trial design aims to overcome geographic and logistical barriers to clinical trial participation by leveraging technology and innovative research practices. Geographic barriers often include the need for patients in rural or remote areas to travel long distances to access trial sites, which can be prohibitively expensive and time-consuming. Logistical challenges may involve difficulties such as arranging frequent in-person visits, balancing trial participation with work or caregiving responsibilities, and accessing specialized medical or research facilities. For example, oncology clinical trials frequently require advanced imaging or laboratory tests available only at select urban centers, creating accessibility issues for patients residing in remote and underserved areas. DCTs can address these barriers by incorporating virtual consultations, remote patient monitoring, home delivery of trial medications, and collaboration with local health care providers who can conduct certain trial-related testing and procedures.

However, current regulatory and oversight standards for DCTs often lag behind technological advancements, creating challenges in implementing remote trial components while maintaining compliance with traditional research protocols. Ambiguities in PI oversight responsibilities, site monitoring requirements, and the role of telemedicine in clinical assessments have led to inconsistencies in how DCTs are conducted and evaluated across different regulatory bodies. Additionally, a lack of awareness and the failure to integrate decentralized trial elements into the work- flow are common challenges.

Strategic Actions

Refine regulatory and oversight standards: Federal and state government advocacy by researchers, providers, and trial sponsors for flexible PI oversight standards and clarification of personnel requirements in decentralized settings is necessary to accommodate this innovative trial model. Steps must be taken to ensure that regulatory frameworks align with the practical needs of DCTs.

Educate stakeholders: Informing stakeholders about the benefits of DCTs is necessary to overcome hesitation and reshape perceptions. This will involve disseminating data that demonstrate the ability of DCTs to improve patient access and streamline operational efficiency, without compromising scientific rigor or patient safety. Using data to reinforce the narrative that DCTs can augment trial participation by being patient-friendly and accessible can build trust among patients, institutions, and regulatory bodies alike.

Develop an oncology-specific DCT manual: A comprehensive DCT manual specific to oncology research would serve as a central resource for trial sites and stakeholders. The document should feature detailed case studies that shed light on DCT success stories, operational guidance to help interested sites get started, funding models to ensure financial feasibility, and flowcharts detailing various DCT configurations tailored to oncology-based clinical trials

Partner with community health resources:

DCTs often collaborate with community health centers, pharmacies, or local clinics to facilitate trial activities such as specimen collection, routine monitoring, and patient education. In addition to building trust within communities, these efforts streamline trial logistics by utilizing existing infrastructure.

Incorporate the industry sponsor’s perspective:

Engaging industry sponsors early in DCT planning is crucial to aligning study design with regulatory expectations, operational feasibility, and financial sustainability. Sponsors provide critical insights into protocol development, technology integration, and data collection strategies that ensure compliance and efficiency. By incorporating the sponsor’s perspective, research teams can design DCTs that are both scientifically rigorous and commer- cially viable, while mitigating risk and increasing the likelihood of trial success using a decentralized model.

Strategic Actions

Leverage AI and digital tools*:

Wearable devices, electronic PROs (ePROs), and other remote data collection technologies enable continuous, accurate, and real-time monitoring of patient health. This reduces the need for in-person consultation while ensuring robust data collection. Digital data recording also has the potential for automated data reporting and analysis.

Refine regulatory and oversight standards:

Federal and state government advocacy by researchers, providers, and trial sponsors for flexible PI oversight standards and clarification of personnel requirements in decentralized settings is necessary to accommodate this innovative trial model. Steps must be taken to ensure that regulatory frameworks align with the practical needs of DCTs.

Educate stakeholders:

Informing stakeholders about the benefits of DCTs is necessary to overcome hesitation and reshape perceptions. This will involve disseminating data that demonstrate the ability of DCTs to improve patient access and streamline operational efficiency, without compromising scientific rigor or patient safety. Using data to rein- force the narrative that DCTs can augment trial participation by being patient-friendly and accessible can build trust among patients, institutions, and regulatory bodies alike.

Widespread adoption of DCTs, supported by feasible oversight standards, targeted educational resources, and stakeholder messaging will allow this innovative research model to address persistent geographical and logistical barriers to oncology clinical trial participation for underserved populations. DCTs can reduce overhead costs associated with operating centralized trial sites, such as facility maintenance and staffing. Community-based approaches optimize resource allocation, making clinical trials more cost-effective and scalable. Conducting trials in familiar community environments will have the added benefit of building trust between researchers and local participants. Trust is partic- ularly critical in underserved populations that may harbor historical skepticism toward medical research. Growth of the decentralized model will enable more clinical trials to be conducted within community cancer centers, thereby enhancing accessibility and representation within cancer clinical research.

Resources

Manual for Conducting Clinical Trials with Decentralized Elements

| US Food and Drug Administration (FDA) | Guidance for industry, investigators, and other interested parties

Decentralized Trials: Bringing Clinical Trials Closer to the Patient

| LUNGevity | Blog describing DCTs for lung cancer clinical research

The DCT Tubestop Map | Decentralized Trials and Research Alliance (DTRA) | Overview of DCT planning

Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals During COVID-19 | AACR | Real-world case study of DCT in practice

Build evidence and trust:

Transparent AI model development and clear communication about AI applications are needed to foster trust among patients, investigators, and regulators. Detailed information should be shared openly, including algorithms, code, data sources, and rationale for use in decision-making processes. AI can also analyze complex datasets to refine trial designs and ensure that eligibility criteria are both flexible and scientifically robust. These AI-driven insights could identify previously overlooked patient populations suitable for therapeutic trials as well as overly specific eligibility criteria.

Strategic Actions

Leverage artificial intelligence and digital

health tools for clinical trial efficiency

Artificial intelligence (AI) holds the potential to transform clinical trial processes by addressing inefficiencies and barriers that hinder participant recruitment and operational workflows. Currently, challenges such as identifying eligible patients from broad back- grounds, managing large datasets, and coordinating complex trial operations often slow progress and increase costs. AI solutions can streamline these processes by leveraging tailored algorithms to analyze EHRs, predict patient eligibility, and optimize scheduling and resource allocation. By automating labor-intensive, scalable tasks, AI reduces administrative burdens and can also enhance trial representation. While the possibilities within AI are vast, a focus on usability, interoperability, and transparency is necessary to ensure efficient and ethical approaches to technology use in clinical trials.

Focus on usability and interoperability:

AI tools should integrate seamlessly with existing systems, especially EHRs and search functions such as clinicaltrials.gov. Intuitive applications should be developed for existing clinical workflows, such as virtual waiting rooms, automated protocol simplification, and real-time participant tracking systems. These tools will not only reduce operational burdens on trial coordinators and staff, but also streamline patient interactions, minimizing delays and optimizing efficiency. For example, AI-powered scheduling platforms can coordinate trial visits, reducing logistical hurdles for both patients and staff. Additionally, advanced data analytics should proactively identify potential issues, enabling timely course corrections to ensure trial success. To maximize efficiency and reduce administrative complexity, it is crucial to focus on the interoperability of systems and minimize the use of separate platforms with multiple logins, which can hinder seamless integration and create unnecessary barriers.

Leverage AI and digital tools*:

Telehealth can facilitate clinical trial access and feasibility by reducing geographic and logistical barriers for study participants while streamlining trial operations. Telehealth allows for real- time communication between patients and research teams, which can potentially minimize dropout rates, enhance data collection, and ultimately accelerate the development of novel therapies.

Virtual consultations enable patients in remote or underserved areas to connect with research sites without the need for extensive travel, broadening the pool of eligible participants.

Additionally, remote monitoring tools, such as wearable devices and mobile health applications, allow for continuous data collection, enhancing protocol adherence and reducing the burden of in-person visits.

AI and digital tools offer significant opportunities to promote representation and efficiency in clinical research. By automating routine tasks, a significant administrative burden can be alleviated, freeing clinical trial staff to focus on the clinical and scientific integrity of the trial itself. AI models can be used during the trial design process to analyze information contained within EHRs for protocol optimi- zation purposes, ensuring eligibility criteria are thoughtful and evidence based. Transparent development processes, including the data and algorithms used, will be essential to build confidence among patients, researchers, and regulators alike. AI is uniquely positioned to address many of the current challenges that exist for clinical researchers in the community setting.

Resources

Trial GPT | National Institutes of Health (NIH) | An AI algorithm to match volunteers to clinical trials

Principles for the Responsible Use of Artificial Intelligence in Oncology | American Society of Clinical Oncology (ASCO) | Position paper with 6 guiding principles

Expanding Clinical Trial Accessibility in the Digital Era With Tele- medicine | JAMA Oncology | Suggestions for using telemedicine to expand clinical trial access to rural populations and racial and ethnic minority groups

Meeting Patients Where They Are: Policy Platform for Telehealth and Cancer Care Delivery | Journal of the National Comprehensive Cancer Network (NCCN) | Policy recommendations for the use of telehealth in oncology

Multiannual Artificial Intelligence Workplan 2023-2028: HMA-EMA Joint Big Data Steering Group | European Medicines Agency (EMA) | Workplan with regulatory framework to guide the use of AI in medicine in Europe

EMA Adopts Reflection Paper on the Use of Artificial Intelligence (AI) | BioSlice Blog | Commentary on legal and regulatory devel- opments involving AI and European life sciences

Conclusion

As the oncology clinical research landscape continues to evolve, equipping community cancer centers with operational efficiency, an empowered workforce, and strong relationships with the surrounding community will be essential to maximize the recruitment of study participants from broad backgrounds. Representative clinical trial design, which reflects the true variegated backgrounds of the patient populations it aims to serve, holds the potential to significantly improve cancer care delivery, ensuring that treatment innovations benefit all patients regardless of back- ground, age, comorbidity, or geographical location. By expanding eligibility criteria, leveraging decentralized trial models, and bolstering the clinical research workforce, trials can become more accessible, breaking down barriers that have traditionally excluded underrepresented groups.

To effectively advance these strategic actions, more formally structured partnerships are needed among the following key stakeholders:

• Government agencies (eg, FDA, NIH, Centers for Medicare & Medicaid Services)
  
• Oncology professional societies
  
• Patient advocacy groups
  
• Industry partners
  
• Academic institutions
  
• Community cancer centers
  
• Health care networks

The strategic actions discussed throughout this paper, including the development of a more representative clinical trial workforce, the optimization of trial designs, and the integration of advanced technologies such as artificial intelligence, are critical components of realizing the future of representative oncology research.

Advancing these initiatives not only fosters fair research environments but also enhances the generalizability and real- world applicability of clinical research findings. A multifaceted approach, combining the strategic actions outlined above, will pave the way for a more just and effective cancer research para- digm. By addressing the systemic challenges that have historically hindered participation in clinical trials, we can ensure that the next generation of cancer care is not only scientifically rigorous but also representative and accessible to all.

This convening of multifaceted stakeholders marks a crucial first step toward reshaping the clinical trial ecosystem. By bringing together leaders from across the research spectrum, we have set the stage for transformative progress in trial accessibility and inclusivity. In the end, true progress is only possible when we unite our unique strengths and areas of professional expertise to drive meaningful change in representative clinical trial design.

Nicole A Colwell, MD is a senior editor/medical writer at the Association of Cancer Care Centers (ACCC) in Rockville, Maryland. Kimberly Demirhan, MBA, BSN, RN is assistant director, education programs at the Association of Cancer Care Centers (ACCC) and program director for ACCC’s Community Oncology Research Institute (ACORI) in Rockville, Maryland.

References

1. Braun-Inglis C, Boehmer LM, Zitella LJ, et al. Role of oncology advanced practitioners to enhance clinical research. J Adv Pract Oncol. 2022;13(2):107-119. doi:10.6004/jadpro.2022.13.2.2
2. Vidal L, Dlamini Z, Qian S, et al. Equitable inclusion of diverse populations in oncology clinical trials: deterrents and drivers. ESMO Open. 2024;9(5):103373. doi:10.1016/j.esmoop.2024.103373

ACKNOWLEDGMENTS

Thank you to the attendees of the ACORI Summit who contributed their thoughts and voices to the priority area discussions.

Participants

Al B. Benson III, MD, FACP, FACCC, FASCO

Professor of Medicine

Northwestern University Hospital

Audrey Davis, LPC

Senior Director, Health Equity

Cancer Support Community

Beth Faiman, PhD, MSN, APN-BC, BMTCN, AOCN, FAAN, FAPO

Nurse Practitioner

Cleveland Clinic

Brandy Heckman-Stoddard, PhD, MPH

Acting Director, NCI Community Oncology Program

National Cancer Institute

Candice Roth, MSN, RN, CENP

Executive Director

Academy of Oncology Nurse Navigators, Inc. (AONN+)

Carrie Friedman, RN Clinical Trials Navigator Virginia Cancer Specialists

Cassadie Moravek, BS

Senior Director, Clinical Trial Portfolio and Program Manager

Pancreatic Cancer Action Network

Colleen Lewis, MSN, ANP-BC, AOCNP

Vice President, Nursing & Research

Florida Cancer Specialists & Research Institute, LLC

Diane Bruessow, MPAS, PA-C, DFAAPA

Director, Justice, Equity, Diversity, and Inclusion, Assistant Professor

Yale School of Medicine PAO Program

Elif Andac-Jones, PhD Vice President, Research Tigerlily Foundation

Erin Pierce, NP

Clinical Investigator/Manager of Center for Innovative Cancer Therapies

Ochsner MD Anderson Cancer Center

Ishwaria Subbiah, MD, MS, FASCO Executive Director, Cancer Care Equity The US Oncology Network & SCRI

Jan Baranski, PhD

Director, AACR Center for Cancer Clinical Trials

American Association for Cancer Research

Jane Myles, MSc

Program Director

Decentralized Trials and Research Alliance

Jeff Allen, PhD

President & CEO

Friends of Cancer Research

Jennifer Bires, LCSW Executive Director Inova Schar Cancer

Jimmy Bechtel, MBA

Vice President, Site Engagement

Society of Clinical Research Sites (SCRS)

Kathleen Wiley, MSN, RN, AOCNS Director, Oncology Nursing Practice Oncology Nursing Society

Laura Levit, JD

Senior Director, Research Analysis and Publications

American Society of Clinical Oncology (ASCO)

Lauren Zion, PharmD

Oncology Pharmacy Clinical Specialist

Nevada Oncology Society; Renown Pennington Cancer Institute

Lawrence Wagman, MD Regional Medical Director City of Hope

Lora Black, RN, MPH, CCRP Vice President, Clinical Research Sanford Health

Marie Rahne, MBA

Director

Minnesota Cancer Clinical Trials Network (MNCCTN)/ Univer- sity of Minnesota

Max Coppes, MD, PhD, MBA

Director, William N. Pennington Cancer Institute

Renown Health

Melissa Miller, PhD, MPH

Research Director

Inova Schar Cancer

Michele Lacy, RN, BSN, OCN

Senior Director

Metro Minnesota Community Oncology Research Consortium (MMCORC)

Nadine Barrett, PhD, MA, MS

Professor, Social Science and Health Policy, Division of Public Health Sciences

Atrium Health

Nazila Shafagati, MD

Oncology Fellow

Johns Hopkins Medicine

Nicole Gormley, MD

Division Director

US Food and Drug Administration (FDA)

Nicole Stout, DPT, FAPTA

Senior Director, Survivorship and Wellness

American Cancer Society

Noelle Gaskill, MBA

Vice President, GM of TIME Research Network

Tempus

Patrick Harrington, PhD

Senior Vice President, Strategic Solutions

WCG

Regina Barragan Carrillo, MD

Postdoctoral Fellow

City of Hope Comprehensive Cancer Center

Renea Duffin, MPA, FACCC

Vice President, Cancer Outreach and Clinical Trials

Mary Bird Perkins Cancer Center

Richard Lush, PhD

Director, GWCC Clinical Trials Office

George Washington University Cancer Center

Robert Winn, MD

Director

VCU Massey Comprehensive Cancer

Robin Lockhorst, PharmD

Oncology Research Administrative/Pharmacy Manager

Hematology/Oncology Pharmacy Association (HOPA)

Selin Kurnaz, PhD Co-founder and CEO Massive Bio

Shaalan Beg, MD

Senior Advisor for Clinical Research

National Cancer Institute

Sharon Shriver, PhD

Senior Analyst, Policy Analysis and Legislative Support, Emerging Science

American Cancer Society Cancer Action Network (ACS CAN)

Shonta Chambers, MSW

EVP Health Equity and Community Engagement

Patient Advocate Foundation

Soumya Niranajn, BPharm, MS, PhD,

Associate Professor

University of Alabama at Birmingham

Stephanie Petrone, MLS (ASCP)

Facilitator

Navigate Clinical Consulting

Stephanie Van Bebber, MSc, CCRP

Senior Director, Research

Inova Schar Cancer

Tiffani Kirkpatrick, PharmD

Research Quality Manager, Research Pharmacist

Avera Cancer Institute

Wendy Vogel, FNP, AOCNP, FAPO

Executive Director

Advanced Practitioner Society for Hematology and Oncology (APSHO)

Whitney Meeks, RN

Clinical Trial Nurse Navigator

The Leukemia & Lymphoma Society

Sponsors

Catherine Wangui Wachira, MD, MBA, MPH Senior Group Director Scientist, Hematology R&D AstraZeneca

Jamie Cairns, BSc(Hons)

Executive Director, Clinical Trial Enrollment Expansion

Eli Lilly and Company

Jenessa Lee, PharmD Medical Science Liaison Sanofi

Joe Scattergood

Vice President, Oncology Clinical Trial Enrollment Expansion

Eli Lilly and Company

Kathleen Reed, MS RN Director, External Partnerships AstraZeneca

Kathy Wojtas

US Medical Affairs, Medical Lead, CLL

AstraZeneca

Kemi Williams, MBA

Senior Director, Patient Science

AstraZeneca

Maria Khasminsky, PharmD, MBA

Medical Science Liaison

Sanofi

Matt Farber, MA

Oncology Environment Shaping

Eli Lilly and Company

Michelle Brockman, MBA

Head, Strategic Evidence and Collaborations, USMA

Gilead Oncology

Mir Mahmood, PharmD Senior Medical Science Liaison Sanofi

Nicole Rule, MBA

Associate VP, Oncology Clinical Trial Acceleration

Eli Lilly and Company

Pamela Brill, RN, MSN, CPNP

Field Scientific Director

Sanofi

Rosa Kim

Associate Medical Director, CLL

AstraZeneca

Sabrina Meyers, PharmD

Senior Director, US Medical Affairs

Gilead Oncology

Scott Welden, MS

Associate Director, Oncology Strategy and Operations

Gilead Oncology

Tricia Reese

Director, Clinical Site Partnerships

Gilead Oncology

Staff

Adriana Kiewra

Associate Manager, Association Services

Cassandra Marakov

Senior Marketing Manager

Elana Plotkin

Senior Director, Education Programs

Karen Fecenko-Tacka, PhD

Chief Program and Content Officer

Kimberly Demirhan, MBA, BSN, RN

Assistant Director, Education Programs

Latha Shivakumar, PhD

Senior Director, Clinical Education and Research

Meagan O’Neill, MS

Executive Director

Molly Kisiel, MSN, FNP-BC

Director, Clinical Content

Nicole Colwell, MD

Senior Editor/Medical Writer

Rachel Morrison Brown, MPH

Editorial Coordinator

This project was made possible with support from AstraZeneca, Eli Lilly and Company, Gilead Oncology, and Sanofi.

Learn more about ACCC Community Oncology Research Institute at accc-cancer.org/ACORI.

The Association of Cancer Care Centers (ACCC) provides education and advocacy for the cancer care community. For more information, visit accc-cancer.org.

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