ACCC Research Highlights Quest to Boost Trial Enrollment, Address Disparities

The need for more patients in clinical trials and especially more patients from diverse backgrounds hasn’t gone away, based on results from presented Wednesday evening at the opening of the Association of Cancer Care Centers (ACCC) 51st Annual Meeting & Cancer Center Business Summit, held in Washington, DC.

ACCC’s poster session featured several projects aimed at recruiting more patients from community practice settings, including those who face barriers to taking part in studies or have lingering doubts about the process. Authors for one project stated that community oncology practices see 85% of patients diagnosed with cancer, yet only 3% of these patients end up enrolling in a trial.¹

Clinical trial enrollment | Image: FreePik

In June 2024, FDA issued a draft guidance on the need for clinical trials to enroll study populations that would more closely align with the patient groups who would take the therapies being studied. Shortly after the start of the Trump administration, that guidance was removed from the FDA website, although officials recently restored it, citing a court order.

Data collected by FDA in 2021 showed that 75% of patients taking part in clinical trials were White¹ while US Census estimates put the share of the population that is White alone at 58%, based on US Census estimates. By contrast, 11% of the clinical trial population was Hispanic and 8% of the patients were Black, both below their representation in the population, which are 19.5% and 13.7%, respectively. These disconnects mean clinical trial results may not hold up when drugs are used real-world settings; for payers, this can mean unforeseen adverse effects, hospitalizations, or more cases of patients abandoning an expensive drug.

ACCC has been working with the American Society of Clinical Oncology(ASCO) to improve diversity in clinical trials since 2020, and last year the ASCO-ACCC Initiative launched “Just Ask,” a toolkit to help community providers and research sites talk with patients about clinical trials.

Results From the ACORI Summit

A poster summarized efforts by the ACCC Community Oncology Research Institute (ACORI) to bring together multiple stakeholders October 29-30, 2024, to brainstorm on strategies to improve clinical trial design with the goals of improving enrollment and removing barriers for underrepresented groups. Those represented included 24 cancer center providers, 17 industry representatives, 17 partners organizations, 2 technology company officials, and members of the FDA Oncology Center of Excellence, the National Cancer Institute (NCI), and NCORP, the NCI Community Oncology Research Program.

“The summit focused on identifying actionable solutions to expand access to clinical trials by optimizing clinical trial design, employing innovative delivery of trial opportunities, and building consensus for effective strategies around engagement, recruitment, and retention of participants and communities,” the authors wrote.

Summit session topics were artificial intelligence (AI) in trial design, inclusion/exclusion criteria, decentralized clinical trials, industry case studies, trial design for diverse populations, and using advance practice providers (APPs) in clinical research. ACCC committed to keep the stakeholders engaged.

“Patient-centered trial design and accessible research opportunities are essential for improving cancer care,” the authors concluded.

The group identified multiple priority tactics under each broad area of need:

• Strengthen the clinical trial workforce. Tactics included creating more flexible qualifications for clinical research coordinators, supporting training programs, standardizing APP training programs, and building institutional support.
• Optimizing trial designs for real-world populations. Among tactics were greater use of pragmatic trials, continued reassessment of eligibility criteria, simplified protocols to boost adherence, and early engagement of community providers.
• Engage with communities beyond clinical trial interactions.Tactics werebuilding relationships before diagnoses, involve community stakeholders in designs, and addressing barriers through long-term relationship building and action plans that incorporate social determinants of health. Accountability counts, and so does measurement.
• Use decentralized trials.Refine regulations and standards for principal investigator and delegation of authority; inform stakeholders of benefits and create a framework for participation and operational guidance.
• Leverage AI and digital tools. Demonstrate value by measuring impact on enrollment, and advocate for transparency. Use AI for matching patients to trials and centralizing lab operations.

Strategies for More Diverse Enrollment

A poster presented by Kasey Boynton, MPH, senior director, Global Operations & Partnerships for Sanofi, highlighted an array of strategies the pharmaceutical company is deploying to boost enrollment of Black and Latino patients in oncology clinical trials. The authors note that enrollment from these patient groups is lower than enrollment of White patients.

Lack of enrollment from minority patient groups is problematic for several reasons, they said. “A lack of diversity may compromise the generalizability of findings, prevent comparison between subgroups, and worsen existing health disparities,” according to the poster.

Authors from Sanofi used several methods to uncover problems in clinical trial design that led to low enrollment from minority groups, or, in some cases, poor trial adherence for those who did enroll, as Boynton explained. Strategies to identify barriers included collecting patient narratives, conducting community outreach, or deploying site support. Sanofi also developed diversity goals for clinical trials, including goals for specific studies in stem cell transplants and in melanoma.

Changes in clinical trial design moving trial locations, use of mobile trial sites that could travel to patient neighborhoods, and minor adjustments to clinical trial criteria that could help investigators capture large numbers of patients who would otherwise not be eligible. Boynton explained that an adjustment of just 2 points to body mass index criteria, for example, could have a significant impact on enrollment eligibility.

“Applying these tactics to other oncology trials may improve low enrollment of minority groups currently observed in such trials, thereby enabling a better understanding of therapy safety and efficacy in minority populations,” the researchers wrote.

Results showed the following:

• Diversity goals were met for at least 2 cancer types in each of the minority populations assessed.
• Strategies were most successful (5 of 7 cancer types) for Asian or Pacific Islander populations, and least successful (2 of 7 cancer types) in the Native American or Alaskan Native populations.
• Diversity goals were met in all groups in the stem cell transplant trials, except for the Native American or Alaskan Native population.
• In the melanoma trials strategies were only successful for the Black population among population groups.

Identifying Barriers to Better Bladder Cancer Care

ACCC has deployed a Plan-Do-Study-Act framework for quality improvement (QI) in other cancer types, and this poster represented the first step in a 6-month QI initiative in bladder cancer. Bladder cancer has seen the approval of novel treatments in frontline care in recent years, yet authors noted that guideline-concordant care occurs in less than 50% of the cases. “Access and care delivery barriers exacerbate this finding,” the authors wrote.

The 3 phases of the project were outlined as a planning phase, a workshop phase, and a post-workshop phase. Results were presented from the planning phase, which included self-assessments of barriers from each of the 3 sites selected to take part in the QI project—one sites each from California, North Carolina, and Kentucky.

Although each site diagnosed a similar number of bladder cancer patients, they varied greatly in the number of cases treated from 2021 to 2022. The California site diagnosed 167 patients and treated 103, with an average age of 74. The North Carolina site diagnosed 200 and treated 330 patients, average age 69; while the Kentucky site diagnosed 200 and treated 1439, average age 71. While the North Carolina site treated English and Spanish speakers, the California and Kentucky sites drew diverse languages that also included Chinese, Japanese, Vietnamese, Filipino, and Arabic (California), as well as French, Albanian, and Portuguese (Kentucky).

All 3 sites had a high share of patients with public insurance; rates of private insurance ranged from 17% to 29%; only California had 0% uninsured.

Barriers identified were both referral and diagnostic delays for California and North Carolina; diagnostic delays were cited in Kentucky. All 3 sites reported limited patient education and limited care resources; California’s site also reported limited supportive care resources.

In addition, California’s site mentioned, “Complex surgeries are referred to academic centers for expertise,” while the other sites reported “limited local specialists.” North Carolina’s site reported care coordination challenges and transportation issues, and Kentucky’s site leaders said reimbursement for certain specialty therapies was difficult.

While the project is ongoing, the authors stated, “QI initiatives that address disparities are feasible with systems-level support and program-specific understanding of barriers to equitable care.”

References

1. Demirhan K, Shivakumar L, Beg S, et al. Enhancing inclusivity in oncology clinical trials: key strategies from the ACORI Community Oncology Inclusive Clinical Trial Design Summit. Presented at: Association of Cancer Care Centers 51st Annual Meeting & Cancer Center Business Summit, Washington, DC; March 5-7, 2025.
2. Boynton K, Adams M, Darkwah I, Szacher M. Strategies to increase enrollment of diverse populations in oncology clinical trials. Presented at: Association of Cancer Care Centers 51st Annual Meeting & Cancer Center Business Summit, Washington, DC; March 5-7, 2025.
3. Khaki AR, Sun F, Hensley PJ et al. Early findings from a National Quality Improvement Program to address disparities in bladder cancer care. Presented at: Association of Cancer Care Centers 51st Annual Meeting & Cancer Center Business Summit, Washington, DC; March 5-7, 2025.