Systems and Providers, Not Patients, Limit Clinical Trial Diversity

BECOME Initiative Aims to Increase Clinical Trial Opportunities

We’ve known for years that Black cancer patients are less represented in clinical trials than white patients – despite strong interest from patients in participating. Stephanie Walker, BSN, says she herself has experienced some of the forces keeping Black metastatic breast cancer patients like her out of trials, including providers who just don’t bring up trials to Black patients as readily as to their other patients.

Research to be shared by Walker during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting suggests some practical strategies – like sharing information on side effects and making available people who share patients’ race and experiences to talk about clinical trials – to reduce this disparity.

“Trial participants should reflect the diversity of the general population. Once that occurs, an oncologist will be able to understand how a drug works across subtypes,” said Walker during an ASCO press conference describing the findings. Although 15% of cancer patients in the U.S. are Black, only 4% to 6% of clinical trial participants are. Walker and her colleagues surveyed 424 patients with metastatic breast cancer, 102 of whom identified as Black, to determine how Black patients’ beliefs about clinical trials compared to those of non-Black patients.

Walker will present her findings at a poster session at the conference, which will take place in Chicago June 3-7. She conducted this work as part of the BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project, an initiative of the Metastatic Breast Cancer Alliance.

Among those surveyed via social media and the Metastatic Breast Cancer Alliance’s membership, 83% of Black patients said they would be somewhat or very likely to consider participating in a clinical trial, but 40% of Black respondents reported that no one on their care team had discussed trials.

“We need to understand where in the system this gap occurs,” Julie Gralow, MD, the Chief Medical Officer and Executive Vice President of ASCO, said during the press conference.

Barriers to Clinical Trial Diversity

Compared to non-Black respondents, Black patients cited a number of beliefs and barriers that might limit their participation in clinical trials. They were nearly twice as likely as non-Black patients to say they believed that unstudied treatments may be harmful, and less likely to say they believed that people of all races and ethnicities get fair treatment in clinical trials. However, compared to non-Black patients surveyed, Black metastatic breast cancer patients were more likely to value receiving information about a clinical trial from Black people and those who have had breast cancer.

“We trust people that look like us, that are from the same racial or ethnic background, those that have participated in clinical trials, those that have had breast cancer, and those that have had metastatic breast cancer,” Walker said.

The findings of the BECOME project mirror the conclusions of research looking into other cancers’ clinical trial disparities, said Tuya Pal, MD, Associate Director for Cancer Health Disparities at the Vanderbilt-Ingram Cancer Center and Professor at the Vanderbilt University Medical Center in Nashville, Tennessee, who was not involved in the research.

“We know that when individuals across the population are approached for clinical trials, many times they will agree to it,” she said. “So we also realize that across populations, not everyone is being asked.”

BECOME Research Project

Next, Walker said, the BECOME project will expand to reach more Black patients like her who live in rural areas, as well as those who are not as connected to the internet.

Walker and her colleagues did not ask patients about whether they knew which clinical trials were recruiting or whether they could travel to clinical trial locations. She said that these factors could also contribute to patterns in clinical trial enrollment. Transportation can introduce an additional cost that patients may not have predicted.

“Dealing with metastatic breast cancer is as overwhelming as it is, and then to have to throw in the expense of a clinical trial – that frightens us as metastatic breast cancer patients,” Walker said. Providers must understand these concerns and others, and emphasize that trials are meant to help, she added.

But care teams must go a step further and work to combat their own conscious or unconscious biases, Walker said. In her own experience as a metastatic breast cancer patient, she said, she only learned of clinical trials after the fact, in part because of providers’ preconceived notions.

“Coming into an office and seeing me sitting there, the information that you were going to discuss with me probably goes out of the window because you see a Black patient,” she said. “You see a patient that is going to be noncompliant, you see a patient that’s not going to finish her treatment plan or somebody that can’t afford it, or someone that can’t understand clinical trials.”

Based on their overall findings, Walker and her collaborators will develop strategies to improve care and increase Black patient enrollment in clinical trials.

Dr. Pal said she hopes the project will also consider systemic barriers to access. For instance, she said, comorbidities like diabetes or hypertension often prevent patients from enrolling in clinical trials, but those health conditions track with social determinants of health that disproportionately affect minority communities.

“Often, the most vulnerable populations aren’t even eligible for clinical trials because of eligibility criteria that we have come up with that excludes them because of their comorbidities,” she added.

What Do Patients With Metastatic Breast Cancer Need to Know?

Based on these findings, Walker said that patients should work with their care teams to figure out what is best for them – but be prepared to do research on their own if they can manage it.

“To help Black patients find a clinical trial, I suggest first of all talking to your physician to find out what clinical trial is appropriate for you and your subtype,” she said. Patient navigators or others whose job it is to guide patients through the health care system may be able to help find relevant, local clinical trials. Additionally, those who have internet access can go online and search for nonprofits that correspond to their cancer types, as these websites will often include areas devoted to upcoming and ongoing clinical trials. The Metastatic Breast Cancer Alliance, for example, has an online registry that matches patients to clinical trials.

Informing patients, inspiring their trust, ensuring access to clinical trials, and addressing concerns are the four pillars that can increase clinical trial participation, Walker said.