AACR Disparities Meeting: Finding Solutions to Diversify Clinical Trials
“If our patients are diverse, why are clinical trials so white?”
Vanessa Sheppard, PhD, invoked this quote from author and activist Ling Song as she began her presentation at the 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.
In her presentation, Sheppard, who is a professor and chair at the Virginia Commonwealth University School of Medicine, focused on efforts to diversify clinical trials, a hot topic during this year’s meeting, held online October 6-8.
Other presenters on this topic included:
- Patricia Doykos, PhD, executive director of health equity at Bristol Myers Squibb
- Stephenie Lemon, PhD, a professor at University of Massachusetts Chan Medical School
- Gary Ferguson, director of outreach and engagement at the Institute for Research and Education to Advance Community Health at Washington State University
- Lorna McNeill, PhD, MPH, a professor and chair at The University of Texas MD Anderson Cancer Center
- Soumya Niranjan, PhD, an assistant professor at the University of Alabama at Birmingham
- Andrea Riner, MD, MPH, a research fellow at the University of Florida in Gainesville
These presenters provided an overview of the current state of minority representation in clinical trials, a summary of the barriers to recruiting minority participants, and some potential solutions to increase diversity in clinical trials.
Although Black and Hispanic Americans make up 13 percent and 16 percent of the U.S. population, respectively, they only account for 3 to 4 percent of patients in clinical trials, with white patients comprising 80 percent of clinical trial participants, according to Doykos.
The lack of minority representation in clinical trials has adverse consequences for the health of minority patients with cancer, including limiting their access to cutting-edge therapies and preventing clinicians from understanding how generalizable a treatment’s safety and efficacy may be to non-white patients.
Patients of color, therefore, often receive cancer therapies that have been studied primarily in white patients and which may not be tailored to the specific characteristics of their cancers or health status. These factors may contribute to the greater mortality rates observed among minority populations for many cancer types.
“Underrepresentation in health-related research is one of the factors that contributes to health disparities experienced by many populations in our country,” noted Lemon.
Several factors contribute to the low enrollment of minority populations in clinical trials, including logistical challenges faced by patients and systemic issues in health care. Patients may decline clinical trial participation due to lack of child care, health insurance coverage, and/or transportation; or due to language barriers and/or low health literacy. In a survey conducted by Sheppard and colleagues, it was apparent that many patients did not understand the benefits of clinical trials and did not realize that they would continue to receive high-quality care as part of the trial. Patients also expressed fear about the possible side effects associated with the research therapy even when the side effects were similar to those associated with the standard-of-care treatment.
Patients of certain races/ethnicities may also opt out of clinical trials due to a mistrust of clinical research that stems from historical injustices and abuses.
“In order to build trust, the historic, systemic reasons for mistrust must be excavated and made visible,” said Ferguson, citing examples of injustices against Indigenous peoples as factors underlying trauma and medical mistrust in these populations. Ferguson added that common concerns among American Indian/Alaska Native individuals revolve around specimen ownership, data access, and research ethics.
Ongoing systemic issues in clinical research are additional factors that contribute to the lack of diversity in clinical trials. Implicit biases among clinicians lead to fewer minority patients being referred to clinical trials, even when these patients are eligible, according to presentations from McNeill and Niranjan. “It must be acknowledged that implicit bias is inherent in all of us as human beings…but it hinders our ability to evaluate equitably, and most importantly, it hinders our decisions,” said McNeill.
She and Niranjan each discussed some of the implicit biases that led providers to withhold clinical trial opportunities from minority patients. These included assumptions about the patients’ ability to understand clinical trials and about their willingness to adhere to study protocols. McNeill and Niranjan noted that many clinicians considered minority patients to be less altruistic and more challenging to work with in a clinical trial setting.
In addition, Doykos noted that clinical trial sponsors are typically not interested in establishing new sites that are more accessible to minority populations due to the associated start-up costs. Moreover, sponsors may avoid using some existing sites, even when they are more accessible, due to the perception that these sites and their staff do not have sufficient experience in running clinical trials.
Study design may also perpetuate disparities. Eligibility criteria for clinical trials often exclude patients with various comorbidities. Due to the prevalence of certain comorbidities among Black patients, these criteria may effectively disqualify Black patients from many trials. Consistent with this idea, results presented by Riner suggested that eligibility criteria related to nutrition and infectious diseases disproportionately excluded Black patients from participating in a pancreatic cancer clinical trial.
“We are creating bias in who may even qualify to participate, and we are sometimes doing so without a truly valid medical reason to exclude someone,” said Riner in an AACR press release. “Alternative eligibility criteria can improve the diversity of participants, provide more equitable access to investigational therapeutics, and reduce disparities in survivorship, without compromising patient safety or study results.”
The Potential Solutions
Addressing barriers is key to increasing diversity in clinical trials. Broadening eligibility criteria, easing logistical challenges, acknowledging historical traumas, building trust among minority communities, and reducing implicit biases were some of the ideas discussed by the presenters.
Presenters also discussed specific initiatives at their institutions that aim to increase diversity in clinical trials by engaging with minority communities, developing materials tailored to the literacy level and cultures of underserved populations, and diversifying the workforce.
TRUST (Teams, Research staff, Use, Spokesperson, Tailor Materials)
Sheppard described the TRUST initiative in place at the Virginia Commonwealth University School of Medicine. This effort focuses on increasing diversity among teams and research staff, utilizing culturally relevant engagement and recruitment strategies, partnering with local media and survivor groups to increase awareness about clinical trials, and tailoring clinical trial materials to the literacy level, geography, and culture of various patient groups. Applying these principles has allowed the researchers to recruit 712 Black participants across four different trials. Many patients expressed high satisfaction with the literacy-appropriate materials that were provided to them, Sheppard noted.
Additional changes under way as part of the TRUST initiative include utilizing dedicated resource specialists who can help underserved patients obtain the resources necessary for transportation, child care, or legal assistance, and dedicated insurance authorization coordinators to help patients determine their coverage for clinical trials. Sheppard and colleagues have also implemented a community education and marketing team to promote clinical trials in local clinics, at community events, and on social media.
STRIDE (Strengthening Translational Research in Diverse Enrollment)
The STRIDE initiative at University of Massachusetts Chan Medical School seeks to improve minority recruitment by creating culturally appropriate and literacy-relevant tools and interventions for the informed consent process through an interactive electronic consent platform (called eConsent). As a companion to eConsent, the program also features personal stories from patients of diverse backgrounds who participated in clinical trials; stories from patients who declined to participate in a clinical trial are also included. In addition, the STRIDE program incorporates simulation-based training for individuals on the research team. This training addresses implicit bias, cultural humility, and appropriate communication with underserved patients.
A central tenet of the program is community engagement, explained Lemon. To this end, STRIDE relies on conversations with community members for feedback on aspects of their protocol. STRIDE also seeks to hire investigators who represent the background of the target community. The effectiveness of the STRIDE intervention in increasing minority enrollment is currently under investigation.
The BMSF-AACR Design and Implementation of Clinical Trials Workshop
To help support diversity in the clinical trial workforce, the AACR has partnered with the Bristol Myers Squibb Foundation (BMSF) to offer the upcoming BMSF-AACR Design and Implementation of Clinical Trials Workshop, to be held virtually November 6-11, for early-career investigators who are underrepresented in medicine.
“This workshop aims to foster clinical trial representation by diversifying the workforce that runs clinical trials and providing those early-career physician-scientists with the tools necessary to engage with the communities they serve,” explained Robert Winn, PhD, a co-chair of the workshop, in an interview with Cancer Research Catalyst.
Increasing diversity in the clinical trial workforce is a key step toward fostering minority participation in clinical trials, he added. “By simply having a doctor from the same racial or ethnic group, patients might be more willing to give clinical trials a serious thought.” Winn is the director of the Virginia Commonwealth University Massey Cancer Center.
The diverse physician-scientists accepted into the workshop will receive hands-on experience designing clinical trials, writing grants, and practicing trauma-informed community engagement. Each participant will also be assigned a mentor, who will help the trainee with career development and provide opportunities to assist with existing clinical trials.
“The workshop will provide education not only in clinical trial fundamentals, but also in health disparities and community engagement,” said Yu Shyr, PhD, another co-chair of the workshop and a professor at the Vanderbilt University Medical Center. “With skills and knowledge across these domains, workshop scholars will be better equipped to build trust with the community—both to explain and answer questions about the clinical trial process, as well as to address, in particular, historical mistrust and the critical need for diverse participation as one step toward eliminating health disparities.”
“With all the progress in targeted and immunotherapy it is imperative we get these drugs to the patients who need them,” added co-chair Roy Herbst, MD, PhD, a professor at Yale School of Medicine. “I am thrilled that with this program, we are rolling up our sleeves to train and build a diverse workforce that will go into the community to provide access to new therapies. Outreach, integration, and building trust are essential and will be key aspects of these scholars’ education.”