Breaking Trial Barriers Through Community-Inclusive Research

Despite significant advances in cancer research, many patients receiving care in community oncology settings, particularly in rural or underserved areas, remain excluded from clinical trials. This exclusion perpetuates disparities in access to cutting-edge therapies and undermines efforts to ensure equitable cancer care.

Understanding the barriers that prevent trial participation in nonacademic settings is essential to developing practical, scalable solutions. Broadly, these barriers fall into 3 interrelated categories: physician related, system related, and patient related.

Physician-Related Barriers:Time, Specialization, and Burnout

Community oncologists often practice in small, high-volume settings where clinical demands leave limited time for in-depth discussions about clinical trials. Unlike subspecialists at academic centers, community oncologists frequently treat a wide spectrum of malignancies, making it challenging to stay abreast of the latest trial opportunities for specific tumor types. In addition, the administrative burden associated with enrolling a patient in a clinical trial—including protocol adherence, regulatory documentation, and data submission—can be daunting, particularly for physicians already facing time constraints and burnout. Without institutional support or dedicated research staff, many clinicians may understandably prioritize delivering standard-of-care treatments over navigating the complexities of trial enrollment.

System-Related Barriers:Infrastructure, Geography, and Coordination

Infrastructure limitations are a major barrier to trial participation in community settings. Historically, clinical trials have required dedicated research personnel (eg, coordinators and data managers), access to specialized diagnostic or laboratory equipment, and collaborative networks for multidisciplinary care. Many smaller practices lack these resources. The up-front financial burden of trial activation, with no guarantee of sustained patient accrual, can also be prohibitive, especially for practices operating on thin margins.

Geographic distance from trial sites presents an additional hurdle. Patients in rural regions may live hours away from the nearest academic medical center, making frequent visits for study-related procedures unfeasible. Even trials that are technically “open” to community settings often require specialist evaluations (eg, ophthalmology for treatments with potential vision toxicity) that may not be readily available locally, further complicating logistics and patient safety monitoring.

Patient-Related Barriers: Awareness, Trust, and Logistical Challenges

Patients receiving care in community settings may not be aware that clinical trials are a viable option. Unlike individuals seeking care at major research centers, they may not expect or inquire about emerging therapies. Many anticipate a conventional treatment plan and may not learn about research opportunities unless their physician raises the topic.

Misunderstandings about the nature of clinical trials are common as well. Patients may have concerns about the safety of investigational treatments, fear receiving a placebo instead of active care, or believe that clinical trials are only appropriate when all other options have been exhausted. Historical inequities, personal experiences, cultural beliefs, or limited health literacy may shape these perceptions.

Even when patients are interested, real-world barriers often interfere with participation. Clinical trials typically require more frequent visits for labs, imaging, and assessments than standard treatment regimens. For patients with limited resources, arranging transportation, taking time off work, or finding childcare may be extremely difficult, particularly without additional support systems. These practical challenges are frequently overlooked in trial design but can represent significant obstacles to enrollment.

Strategies to Broaden Trial Access and Inclusion

Strengthen Academic-Community Partnerships

Strategic alliances between academic centers and community practices can lower activation barriers and distribute resources more efficiently. Shared research coordinators, centralized Institutional Review Board navigation, remote monitoring, and comanaged protocols can enable community sites to participate without duplicating costly infrastructure.

Simplify Trial Design and Decentralize Operations

Pragmatic trial designs tailored for community settings are essential. Streamlining eligibility criteria, minimizing protocol complexity, and incorporating telemedicine or home-based interventions can reduce friction in trial implementation. Prepackaged supply kits, centralized data collection portals, and simplified consent processes also reduce operational burden.

Community Engagement and Supportive Services

Collaborations with local leaders, advocacy groups, and public health entities can foster trust and address social determinants of trial participation. Community-based education campaigns, transportation vouchers, childcare support, and financial navigation services can help mitigate common patient-level barriers.

Targeted Physician Education

Clinical trial communication training is rarely emphasized in medical education or postgraduate training. Physicians need structured guidance on introducing research as a viable, routine part of the care continuum, not as a last resort, and addressing patient concerns with clarity and empathy. Regular updates on trial availability for common malignancies would support informed conversations.

Expand Patient-Facing Educational Resources

Public campaigns that reframe clinical trials as evidence-based, rigorously monitored treatment options—not experiments—are vital. Print materials, videos, and infographics tailored to diverse populations can clarify misconceptions. It is essential to communicate that stringent ethical standards govern modern clinical trials, including independent safety monitoring boards, protocol-driven adverse event reporting, and regulatory oversight. Emphasizing the rigorous preclinical and early-phase testing that precedes large human trials can help allay fears about safety and efficacy.

A Call to Action: Making Innovation Equitable

If the promise of precision oncology is to be fully realized, then the opportunity to participate in research must extend beyond academic silos. Access to potentially life-extending therapies should not be dictated by a patient’s zip code, practice setting, or socioeconomic status.

By reducing logistical, perceptual, and infrastructural barriers to clinical trial participation, we can move closer to a truly inclusive research ecosystem—one that reflects the diversity of the cancer population and ensures that all patients have a seat at the innovation table.

Dr Balanchivadze is a medical oncologist and hematologist at Virginia Oncology Associates in Norfolk, Virginia, specializing in caring for patients with breast cancer. She is board certified in medical oncology, hematology, and internal medicine. For more information, visit virginiacancer.com.