Every day in the United States, thousands of people are diagnosed with cancer, but very few are offered the opportunity to participate in a clinical trial, and only a small fraction of those come from underrepresented populations, according to Carmen E. Guerra, MD, MSCE, FACP, associate director of Diversity and Outreach at Abramson Cancer Center in Philadelphia. However, navigators are in a unique position to increase awareness of bias against underrepresented populations in cancer care, particularly as it applies to their unequal representation in clinical trials.
At the AONN+ 13th Annual Navigation & Survivorship Conference in New Orleans, Dr Guerra discussed the issue of unconscious bias against older and minority patients in cancer care, as well as resources for supporting change.
“Patient navigation is one of the most powerful interventions to mitigate disparities in healthcare,” she said. “Often, navigators do this by really understanding and communicating patients’ desires, preferences, and values to the rest of the care team. That’s critical because sometimes the rest of the team is working on assumptions, which can lead to bias.”
The Issue with Underrepresentation
Only 3% to 5% of patients diagnosed with cancer ever enroll in oncology clinical trials; only a small fraction of those patients is underrepresented, including adults older than 70 years, racial/ethnic minorities, or those from rural populations.
This underrepresentation of diverse patients in trials results in fewer opportunities to access new, cutting-edge therapies, and it also threatens the efficiency of the research.
“In other words, if you’re not enrolling from all of the possible patients out there, you’re slowing down the recruitment process, which hurts us all because it takes longer to learn the trial results and whether we have the ability to determine if there’s a potential new cure for cancer,” Dr Guerra explained. “It also threatens the generalizability of those results.”
Research demonstrates that most patients are not offered participation in a clinical trial by the investigators and referring physicians who are the gatekeepers to these trials (studies show that the proportion of patients not offered a trial ranges from 19% to 76%). However, a meta-analysis of almost 10,000 patients with cancer showed that more than half actually do accept when offered to participate. Importantly, the research showed no statistically significant difference in participation rates by race, disproving the theory that underrepresented minority patients are less likely to agree to participate in clinical trials.
One major reason why individuals may not be offered clinical trials is unconscious bias on the part of providers. Unconscious bias is defined as the automatic social stereotypes that individuals form about groups of people outside of their own conscious awareness.
“Put simply, biases are the automatic assumptions we make up about people before we learn who they are,” said Dr Guerra. “As much as we might want to think that we’re not biased, it’s been shown that all humans have biases. If you’re human, you are biased.”
One common measure of bias is the Implicit Association Test, produced by Harvard University. The results from 10 million of these tests show that 75% of the US population has a pro-White/anti-Black bias, and about 50% of the US population who identify as Black also have a pro-White/anti-Black bias. In addition, 76% of the US population, including both men and women, have a pro-male/anti-female bias.
A meta-analysis of 20 years of studies covering sources of pain in numerous settings found that Black/African American patients were 22% less likely than White patients to receive any pain medication; another study found that women and Black patients were 40% less likely to be referred for cardiac catheterization than men and White patients.
According to Dr Guerra, these biases heavily influence our attitudes about the world and strongly dictate our behavior toward the people in it. “This can result in either microaffirmations or microaggressions against individuals,” she said. “This bias greatly impacts the care that we provide, as well as clinical trial recruitment. However, the good news is that bias can be interrupted.”
Interrupting Bias in Recruitment to Clinical Trials
Combating bias in clinical care requires a number of different approaches, depending on the type of unconscious bias displayed.
“Ageism” manifests as assumptions that older individuals are weaker, sicker, and more cognitively impaired, which leads to differences in communication and treatment (ie, “Elderspeak”—speaking more slowly/loudly, and using simplified sentences). Ageism results in undertreatment, as well as suboptimal cancer screening and lower clinical trial participation in individuals older than 70 years.
Overcoming ageism requires first recognizing that age alone is not a reliable indicator to guide treatment decisions; this is due to a wide variability in health and functional status among older individuals, as well as gender differences in aging (ie, women have a longer life expectancy than men).
A “Geriacentric” approach to ageism can combat this common type of bias by providing care coordination, navigation, and support to older patients in clinical care settings, using patient-reported outcome tools to screen patients for their specific needs, and using a geriatric assessment (GA) to reduce bias and provide actual data for clinicians and older adults to make informed decisions about their care. A review of GAs is available from the Association of Community Cancer Centers (ACCC): Practical Application of Geriatric Assessment: A How-To Guide for the Multidisciplinary Care Team (accc-cancer.org).
Tools such as ePrognosis, available at ucsf.edu, allow for cancer screening recommendations tailored to each specific individual, not relying on age alone.
“It’s important to expand clinical trial inclusion beyond using age alone, which recently the FDA and other organizations have been championing,” said Dr Guerra. “Perhaps we could stratify individuals by life expectancy and predicted treatment tolerance, rather than by age. Lastly, we can offer access to trials to these individuals, as well as the social and financial support that would allow them to participate.”
Bias Toward Underrepresented Minorities
A study consisting of 91 qualitative interviews conducted at 5 US cancer centers revealed themes about minority patients and why they’re underrepresented in clinical trials.
“At the 5 cancer centers that participated, the research team interviewed cancer center leaders, principal investigators, referring clinicians, and research staff to try to determine how unconscious bias plays out when offering clinical trials to patients,” she explained.
Five specific themes emerged about the recruitment of minority patients:
- Minorities are perceived to be more challenging: racial/minority groups were perceived to have low knowledge of cancer clinical trials and were considered a hindrance while explaining clinical trials in the face of limited provider time during a clinical encounter. Language barrier was also a hindrance to enrolling minorities with limited English proficiency
- Minorities are not perceived to be ideal study candidates: perceptions about protocol compliance impacted decisions of whether to refer or recruit Black and Hispanic patients
- Racial and ethnic stereotypes impacted perceptions and decisions to offer trials: (ie, the perception that some racial groups are more altruistic than others)
- A legacy of mistreatment of Black patients: leads to perceptions of their lack of interest in participation in trials
- Participants also reported that the combination of real clinic-level barriers (such as transportation), in addition to these negative perceptions of minority study participants, led to providers withholding clinical trial opportunities from potential minority participants
Addressing Bias in Underrepresented Populations
When it comes to the issue of trustworthiness, reframing the problem from distrust by minority patients to trustworthiness of research institutions can be a useful tactic.
“When we say the Black population is distrustful, it feels like we’re blaming the victim for the problem, when in fact we should be taking a look at the trustworthiness of our own organizations, of the institutions that we serve, and even science in general,” she said. “About one-third of African Americans say they have experienced discrimination at a doctor’s office or health clinic, and that has led to this erosion of trust.”
According to Dr Guerra, being self-aware that bias does occur—in all of us—is the first step to addressing it in cancer care.
“People who work in a fast-paced environment are more prone to bias, so one strategy is to slow down,” she said. “We’re also more likely to make biased decisions when we’re stressed or tired, and slowing down can help mitigate those feelings.”
Another strategy involves transparency and inquiry. “Instead of making assumptions, ask, but if you have to make assumptions, check to see if the data that you’re using to make those assumptions are correct,” she advised.
When data are unavailable and assumptions must be made based on a person’s comments or behavior, remember the acronym “MRI”—“Most Respectful Interpretation”—and consider the other person’s perspective. For example, if a student repeatedly falls asleep in class, consider factors that might be contributing to this, rather than jumping to the conclusion that they’re disrespecting the class and instructor.
Assuming Positive Intent is yet another strategy. Often, people are unaware that their communication is harmful; simply asking their intent can clear up any miscommunication.
Unconscious bias can be mitigated through the practice of cultural humility. “Instead of assuming you know about a culture, this practice allows you to approach the situation in a way that shows you want to co-learn, continuously create better self-awareness, and think introspectively about those things you’ve learned,” she noted.
ACCC and the American Society of Clinical Oncology have recently developed the first cancer-specific implicit bias training program. “Just ASK! Increasing Diversity in Cancer Clinical Research” enables clinicians and staff to assess and mitigate biases regarding who is screened for and offered clinical trials. More information on this curriculum-based training program is available at www.asco.org/asco-accc.
Finally, it’s important to note that people are difficult to change and have been hardwired for biased thinking. According to Dr Guerra, bias can only really be interrupted by changing the structures, processes, practices, and policies that support healthcare providers in day-to-day practice.