Best Practices for Boosting the Enrollment of Underserved Populations in Cancer Clinical Trials

Coral Omene, MD, PhD, Medical Oncologist and Program Director, Breast Cancer Disparities Research, Rutgers Cancer Institute; Associate Professor of Medicine, Rutgers Robert Wood Johnson Medical School

Mariam Eskander, MD, MPH, Surgical Oncologist, Rutgers Cancer Institute; Assistant Professor of Surgery, Rutgers Robert Wood Johnson Medical School

Sponsored by: Rutgers Cancer Institute / RWJBarnabas Health

It is essential that the racial and ethnic composition of participants in cancer clinical trials reflects that of the general population so that new therapies developed and approved as outcomes of the trials are effective for everyone.

Unfortunately, this often is not the case. The percentage of patients who are Black (or African) Americans and Hispanic taking part in clinical studies is substantially lower than their racial distribution in the US based on 2020 census data. Both minority groups are underserved in clinical trial enrollment. According to 2018 data from the FDA, of more than 5000 patients who took part in trials resulting in 17 new drug approvals, patients who are Black comprised only 4% and Hispanics also only 4% of the study participants, while patients who are White (or non-Hispanic White) accounted for 68%. This is despite the fact that Hispanics represent 19% of the country’s population, and Black Americans represent 12%.

There are numerous barriers for these patients to take part in trials, mostly of a social, cultural, or economic nature. There also are numerous interventions and “best practices” that an institution can adopt to engage underserved patients and spur their enrollment in studies.

Barriers to Clinical Trial Participation

Barriers to clinical trial enrollment span from the individual to the structural/institutional.

These include transportation to the study site, the cost of participating, the burden on their caregiver(s), language, education, health literacy, and lack of awareness of the trials.

Medicaid beneficiaries, in particular, have cited such hurdles as fear of adverse effects or negative results, concerns about additional costs or out-of-pocket expenses, the travel distance to trial sites or number of visits per month required to take part, and the complexity of the enrollment process and paperwork.

A particular and unique obstacle for Black Americans is a long-standing mistrust of the medical community grounded in a dark, disturbing, and shameful chapter in our nation’s history. For a couple of centuries, exploitative experiments were conducted on patients who are Black, starting with enslaved women in the 19^th century and perhaps reaching a nadir with the infamous Tuskegee syphilis study that victimized Black males for 40 years and was shut down relatively recently in 1972.

Physicians’ implicit bias and cultural insensitivity present another impediment to enrollment. The institutions running the trials also create stumbling blocks by not establishing sufficient trial sites and using a complicated informed consent process with stringent eligibility criteria that unintentionally exclude populations with multiple comorbid conditions.

The Importance of Social Determinants

Where a person lives – for example, a low-income housing project in a blue-collar town – is a greater predictor of the length of that individual’s life than whether they smoke, drink alcohol, or eat fatty foods without exercising.

The social determinants of an individual’s health include the neighborhood or environment in which they live, access to and quality of their education, access to hospitals and providers, and economic stability. Health behaviors contribute 30% to life expectancy, but social and economic factors are the leading contributor at 40%. They are also a key factor in whether a patient takes part in a clinical study.

In a national analysis of 2.8 million patients with breast, lung, prostate, colorectal, or pancreatic cancer, those living in socially vulnerable neighborhoods were 20% less likely to enroll in a clinical trial. Moreover, social vulnerability decreased the odds of enrollment for patients who are Black by 52% compared with just 12% for patients who are White. This suggests that addressing social vulnerability may also help boost racial diversity.

Interventions and Best Practices That May Help Increase Participation

In recent years, Rutgers Cancer Institute, and RWJBarnabas Health, New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, have adopted practices and policies that have helped increase the enrollment of underserved populations in our cancer trials. Perhaps taking these steps can work for your organization.

1. Raise patients’ awareness – Discuss the option of clinical trials with your patients who have cancer early and often. Share the potential benefits and risks of participation and be transparent.
2. Engage with the community - Engage with and involve community members in the design and implementation of trials to ensure relevance and promote ownership, and partner with minority community groups to build trust and raise awareness.

• Address cost and transportation – Ensure that patients have an upfront understanding of costs, including out-of-pocket expenses. Make trials convenient for patients by having several diverse study sites, offering free transportation to those sites, and removing other logistical barriers.
• Make the trial understandable – Furnish patients with study materials that are readable and accessible.
• Practice cultural humility and sensitivity – Address the historical mistrust of the medical establishment. Analyze stringent enrollment criteria to determine if they inadvertently exclude minority populations, and work to modify the criteria where necessary to promote wider participation.
• Advocate for policy changes that encourage diversity in clinical trials and support efforts to address disparities in health access.

The bottom line is that to bolster and sustain the enrollment of underserved populations, trials must be designed and coordinated to be more patient-friendly to minority groups on a socioeconomic and cultural level.