Advancing Diversity in Oncology Clinical Trials: 5 Key Insights from Clinical Trial Sites

Clinical trial sites share insights on diversity in oncology research

The importance of clinical trial populations reflecting the diversity of real-world patient communities is well understood, from both an ethical and scientific perspective. In recent years, this has been increasingly emphasized by regulatory authorities, with the FDA recently providing updated guidance on delivery of inclusive trials to produce more generalizable and meaningful research outcomes.

To further understand the topic, members of the Precision Site Network recently participated in the Assessing Diversity and Inclusion (D&I) in Clinical Trial Patient Recruitment project.

Spanning independent research sites, community hospitals and academic medical centers, results include data from the sites themselves on what is working, where improvements are needed, and how to navigate the complexities as we move forward in achieving greater diversity in oncology clinical trials.

Key highlights from PSN site surveys

1) Diversity and Inclusion Infrastructure as Standard

Efforts to formalize diversity and inclusion (D&I) practices are well underway:

• 80% of respondents reported having a formal D&I plan.
• 73% have a designated diversity officer or department overseeing these initiatives.
• Nearly 85% have a well-defined strategy in place for recruiting participants from underrepresented populations.
• 100% collect diversity-related patient data, including age, gender, race, and ethnicity, providing a foundation for measuring progress and refining recruitment approaches.

Respondents by institution type

#2 Evolving the Diversity Definition

Engagement is extending beyond the most commonly studied populations, with targeted recruitment of Black/African-American and Hispanic participants, as well as outreach to patients of lower socioeconomic status, older adults, and LGBTQIA+ communities.

Community engagement stands out as an integral part of these initiatives, and institutions such as hospitals and academic centers often prioritize regular outreach—ranging from monthly to quarterly efforts—to build trust and foster long-term relationships.

#3 Community Engagement is Paramount

Lack of patient trial awareness and trust emerged as critical barriers to achieving more diverse enrollment. One hundred percent of respondents emphasized the need for stronger partnerships with local organizations, indicating that building and maintaining community relationships is essential.

Patient education materials, staff training, and additional funding for site-based initiatives were also identified as important factors to help counter misconceptions, enhance credibility, and empower more patients to participate.

PSN sites identified these top barriers to achieving D&I in patient recruitment

#4 Simplifying Trial Design For Success

Aligning strategies with FDA recommendations for more inclusive trial design can help broaden participation, in the US and beyond. Respondents indicated a need for simplified eligibility criteria to support the inclusion of a wider range of participants who may have been previously excluded due to stringent protocol requirements.

Addressing communication barriers—such as providing materials in multiple languages—along with accommodating cultural differences, can make the research experience more accessible and improve the trial experience for patients from underrepresented communities.

Sites indicated these top challenges in recruiting diverse populations 

#5 Long-Term Collaboration to Reduce Barriers

Even with these encouraging developments, challenges remain. The top obstacles reported included a pervasive lack of patient trust in medical research, limited awareness about clinical trials, and the impact of language barriers.

Additional factors, like study design complexities and cultural differences, alongside logistical challenges such as transportation, further complicate recruitment efforts. Overcoming these hurdles will require long-term collaboration among industry stakeholders and clinical research sites, as well as sustained investment in community engagement and infrastructure to support inclusive research practices.

Breaking barriers to diversity in clinical trials with inclusivity and trust

Findings illustrate that meaningful progress is being made, though significant challenges remain. Addressing barriers to trust, enhancing outreach to underrepresented communities, and aligning trial design with regulatory guidance will help ensure that oncology clinical trials better reflect the true diversity of patient populations.

By continuing these efforts, the research community can produce more equitable and robust results that ultimately serve all patients.