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Addressing Barriers to Clinical Trial Diversity in Oncology

July 2025, Vol 15, No 7

Despite advancements in cancer research, significant racial and ethnic disparities persist in clinical trial participation. At the 2025 Summit on Cancer Health Disparities in Seattle, WA, Yara Abdou, MD, assistant professor of medicine and Breast Cancer Clinical Trial Program leader at UNC School of Medicine and UNC Lineberger Comprehensive Cancer Center, outlined both systemic barriers and actionable strategies needed to improve diversity in oncology trials.

The Urgent Need for Representation

Dr Abdou began by highlighting the stark disparities in cancer incidence and outcomes among racial and ethnic minorities in the United States. Black patients experience the highest cancer-related mortality rates, whereas Hispanic/Latina women are consistently diagnosed with later-stage cancers. Native Hawaiian/Pacific Islander women have higher mortality rates for lung, breast, and cervical cancers, and despite cancer being a leading cause of death among Asian Americans, they are routinely underscreened compared with most Americans.

Minority populations remain underrepresented in cancer clinical trials, undermining understanding of therapeutic efficacy, safety, and biomarker relevance in these groups, while also significantly limiting broader applicability of clinical trial findings. “Diverse representation in clinical trials is essential for developing treatments that are effective and safe for all populations,” she said.

Barriers to Enrollment

Dr Abdou categorized barriers to clinical trial participation into 4 broad domains:

  1. Lack of Awareness
  2. Limited awareness exists on both sides of the patient–provider relationship. Patients may lack access to information about trial opportunities due to language barriers, limited health literacy, or mistrust. On the provider side, clinicians may not be aware of ongoing trials or may be reluctant to refer patients due to unfamiliarity with protocols.

  3. Societal Barriers
  4. Historical injustices, religious and cultural beliefs, and general mistrust in the healthcare system all serve as deterrents to clinical trial participation among minority groups. “This highlights the need for better communication and involvement of trusted advocates to bridge the awareness gap,” Dr Abdou noted.

  5. Practical Barriers
  6. Patients often face financial and logistical burdens, including transportation costs, childcare needs, time off work, and inadequate health insurance coverage. Technological barriers, such as limited Wi-Fi or device access, also inhibit participation in some trials.

  7. Patient Experience
  8. A patient’s overall experience—including language accessibility, cultural congruence with staff, and site convenience—directly impacts their willingness to participate. “Patients are more likely to engage in trials that make them feel respected, that provide flexible scheduling, and that avoid unnecessary intrusions into their personal lives,” she said.

    Young women diagnosed with breast cancer, particularly those aged <40 years, face unique challenges. “These women often juggle work, caregiving, and family responsibilities,” she said, “and are less likely to be aware of or offered trial opportunities.” The disparity is especially stark among young minority patients.

Actionable Strategies to Enhance Diversity

She continued by outlining a multipronged framework for improving clinical trial inclusion:

  1. Cultural Competency and Training
  2. Training research staff in communication, sensitivity, and implicit bias is essential. “Creating an environment where participants feel respected and valued is critical to building trust,” she said.

  3. Diverse Research Teams
  4. Diverse investigators and staff foster trust and relatability with minority participants. Representation at the institutional level signals inclusivity and encourages engagement.

  5. Community Engagement
  6. Partnering with trusted community leaders, such as churches and advocacy groups, can facilitate outreach and education. “I encourage you all to identify such organizations within your state and engage with them early on,” she urged.

  7. Tailored Communication and Technology
  8. Using culturally and linguistically appropriate recruitment materials, as well as leveraging platforms like Facebook, X, or clinical trial–centered mobile apps, can extend trial awareness to more patients.

  9. Transparent Communication
  10. Maintaining open and honest communication about a trial’s goals and risks helps patients feel respected. “Patients need to know how a trial may help them—and how it may help others in the future,” she said.

Retaining Patients: A Critical Metric

Retention is just as important as recruitment. “Research shows that 85% of clinical trials fail to retain enough patients to confirm treatment efficacy,” Dr Abdou noted.

To counter this, she recommended:

  • Regular engagement (eg, newsletters, follow-up calls/texts)
  • Streamlined logistics (transportation assistance, shorter visits, telemedicine options)
  • Education on the trial’s purpose and community relevance
  • Feedback channels to address patient concerns

The Provider’s Role and Looking Ahead

Dr Abdou closed with practical guidance: “Get to know your patients—understand their socioeconomic and logistical challenges. Assess health literacy before discussing a trial. Connect them early to resources like social work, transportation, or mental health support.”

She encouraged addressing implicit bias and leveraging patient navigators to bridge communication gaps, and also highlighted the Robert A. Winn Diversity in Clinical Trials Award Program, which supports early-career investigators in designing community-engaged research. “This kind of investment is key to building the next generation of inclusive clinical trialists,” she said.

According to Dr Abdou, by addressing barriers at multiple levels—from institutional design to clinical conversations—greater trial diversity is both achievable and essential to advancing equity in cancer care.

Source

Abdou Y. Barriers and facilitators to clinical trial diversity. Presented at: 2025 Summit on Cancer Health Disparities. April 25-27, 2025; Seattle, WA.

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