Clinical trials are a vital component of advancing cancer treatment, yet participation rates across the United States remain critically low, particularly among historically underserved populations.
Numerous barriers—including social, financial, geographic, and systemic challenges—continue to limit equitable access to research opportunities. In response, innovative strategies are being developed to bridge these gaps, including enhanced patient navigation services and the integration of digital tools that streamline clinical trial matching.
Recognizing the importance of empowering both patients and healthcare teams, the American Cancer Society (ACS) has introduced new training and support initiatives aimed at improving clinical trial access, education, and engagement. This article highlights the significance of these efforts and their potential to create a more inclusive future for cancer research participation.
A 2024 analysis from the Commission on Cancer revealed that only 7.1% of individuals with cancer in the United States participate in treatment clinical trials.1 While this represents an improvement over past statistics, it underscores the ongoing need for initiatives that increase participation rates. Disparities in participation remain evident across races, ethnicities, and other marginalized communities.2 Barriers include misconceptions about clinical trials, limited awareness or communication regarding available studies, and distrust in healthcare institutions within certain communities or populations.3-5
Research also recognizes that healthcare professionals may possess implicit biases that hinder equitable access to opportunities like clinical trials.6 These biases can be influenced by factors such as race, ethnicity, socioeconomic status, mental health, body weight, language barriers, and insurance coverage.7 Addressing these disparities is crucial for ensuring that all patients have the opportunity to participate in clinical research.
Marginalized individuals often face significant financial and logistical challenges that further hinder their ability—or perceived willingness—to participate.8 Rural communities experience significant disparities, particularly in accessing cancer care and clinical trials. A 2024 study analyzing phase 1 to 3 cancer clinical trials in the United States from 2008 to 2022 showed that only 42.4% of counties had at least 1 active trial. Rural counties, particularly those with lower median household incomes, fewer medical oncologists, and lower cancer incidence rates, were less likely to host clinical trials.9
Furthermore, a 2025 qualitative study of rural cancer survivors identified lack of information, fear of clinical trials, transportation challenges, and physicians not informing them about available trials as major obstacles to trial participation. However, facilitators included understanding the benefits of participation and the importance of clinical trials.10
To address these challenges, patient navigation services can significantly enhance access and potentially boost participation in clinical trials. Navigators are essential in raising awareness and providing support throughout the cancer continuum. The role of a patient navigator includes advocacy for clinical trials, ensuring that patients feel well-informed, safe, and prepared as they make decisions surrounding clinical trials.11 By building strong relationships within both clinical and community settings, navigators provide logistical support, clarify complex information, and foster trust—all essential in improving trial enrollment rates among underserved populations.
Historically, a gap in standardized navigation training programs has led to variability in the support navigators provide.12 Recognizing this, the ACS developed the ACS Leadership in Oncology Navigation (ACS LION) program, a national structured training and credentialing program to equip navigators with up-to-date knowledge of the evolving oncology landscape and tools for assisting individuals affected by cancer. In the first year, ACS LION trained more than 1000 navigation professionals. In January 2025, ACS expanded these efforts by launching the ACS LION Clinical Trials Navigation Certificate. This new educational opportunity is available at no cost and provides oncology professionals with specialized knowledge about clinical trials navigation and up-to-date tools and insights to effectively support patients throughout clinical trials, ultimately making clinical trial information and coordination more accessible across diverse communities.
The ACS LION Clinical Trial Navigation Certificate program has enrolled nearly 200 navigation professionals within just 4 months of its launch. This engagement of ACS LION credentialed navigators shows the critical need for continuous professional development and education on clinical trials within the navigation field and a strong desire to enhance clinical trial knowledge and skills, ultimately aiming to improve practices and support. By fostering a deeper understanding of clinical trials, this initiative empowers both patients and navigators, ensuring that critical clinical trial opportunities are not overlooked. Research has shown that implementing an evidence-based navigation training curriculum can significantly boost navigators’ confidence, understanding of their roles, and knowledge of clinical trials. It was also noted that nonclinical navigation training on clinical trials before entering a multidisciplinary program was needed to build confidence in working alongside the clinical team.13 The ACS LION Clinical Trial Navigation Certificate aims to impact the clinical trial field by bridging training gaps for patient navigators, thereby enhancing their confidence and ability to support patients.
In addition to navigator training, improving the clinical trial–matching process is crucial for increasing patient participation. Many patients, even those motivated to join trials, struggle to navigate complex eligibility criteria and access available studies. Additionally, matching eligible patients to appropriate trials requires a detailed examination of patient records, a process that can be both labor-intensive and time-consuming.14 Many healthcare teams and patients struggle to manage this due to limited staffing and time resources. This disconnect highlights the need for improved communication and resources to ensure that patients can easily access and understand the options available to them.
Digital technologies have become powerful tools to streamline the clinical trial–matching process by reducing logistical barriers for healthcare providers, researchers, and patients, while also helping patients access trials that they may not have been aware of previously.15 A digital matching approach also allows researchers to reach a wider array of participants who may have otherwise been unaware of available clinical trials. By expanding access while reducing logistical challenges, digital matching may enhance the diversity and inclusivity of study populations, leading to more equitable access to clinical trials and research findings that are more representative of all individuals experiencing cancer.
Recognizing the combined power of technology and person-based navigation, ACS launched the Access to Clinical Trials and Support (ACS ACTS) program in February 2025. ACS ACTS leverages AI-driven clinical trial matching to connect patients to personalized clinical trial opportunities while providing comprehensive wraparound support to address health-related social needs (HRSNs; Figure 1). Through ACS ACTS, patients receive clinical trial education, HRSN screening, and assistance with transportation, lodging, and other social needs. Patients, caregivers, and healthcare professionals can access the program by calling the ACS National Cancer Information Center at 800-227-2345, available 24 hours a day and 7 days a week, or by completing the intake form on the program website.
ACS ACTS was launched as a pilot for people who reside in or will travel to receive care in the northeast United States (Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, West Virginia, and Washington, DC). In its first 9 weeks (February 24-April 25, 2025), 299 individuals engaged with the ACS ACTS program, and 216 completed the 1-item HRSN screening question. During this period, 809 health-related social needs were identified, with the top 5 needs being financial needs related to medical care (n=129, 59.72%); financial needs related to housing, food, or utilities (n=118, 54.63%); emotional concerns (n=107, 49.54%); lodging (n=105, 48.61%); and transportation (n=83, 38.43%; Figure 2). These findings emphasize the importance of addressing HRSNs alongside clinical trials education and coordination.
Improving access to cancer clinical trials requires a multifaceted approach that not only addresses systemic and logistical barriers but also empowers patients via education, personalized support, and digital innovation.
Improving access to cancer clinical trials requires a multifaceted approach that not only addresses systemic and logistical barriers but also empowers patients through education, personalized support, and digital innovation. Initiatives like the ACS LION Clinical Trials Navigation Certificate and the ACS ACTS program demonstrate how targeted navigation interventions can close gaps in trial participation, particularly for underserved communities. By building trust, enhancing awareness, and offering comprehensive assistance, these programs lay the groundwork for a more equitable and representative clinical research landscape. Continued investment in navigator education and patient-centered support will be essential to ensuring that every individual facing cancer has the opportunity to explore and benefit from clinical trial options.
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