Research shows that although 15% of Black individuals and 13% of Hispanic individuals have cancer in the United States, only between 4% and 6% of clinical trial participants are Black and between 3% and 6% are Hispanic.1-3 To improve these statistics, in 2020, ASCO and the Association of Community Cancer Centers (ACCC) launched a pilot program to increase racial and ethnic diversity in cancer clinical trials. The program initially involved between 40 and 50 research sites and later included 75 research sites from diverse regions across the United States.
The sites applied to test a research site self-assessment and/or an implicit bias training program, both of which were designed to address the barriers that contribute to low clinical trial participation of people from historically underrepresented racial and ethnic communities in cancer clinical trials and report their findings to ASCO and ACCC.
Lori J. Pierce, MD, FASTRO, FASCO
Based on the feedback from the research sites, in May 2022, ASCO and ACCC published their recommendations on specific actions that all research stakeholders can take to address the barriers to cancer clinical trial recruitment and participation by diverse patient populations to ensure that every patient has access to high-quality cancer research.4 (See “ASCO-ACCC Recommendations to Reduce Barriers to Clinical Trial Enrollment” on page 64).
Later in 2022, ASCO and ACCC will release an implicit bias training program to address disparities in cancer clinical trial participation and a self-assessment for trial sites to record and gauge the number of racial and ethnic patients screened, offered, and enrolled into clinical trials.
Understanding the Barriers to Clinical Trial Enrollment
During the 2022 ASCO Annual Meeting, two abstracts were presented that assessed the feasibility and utility of the ASCO-ACCC implicit bias pilot training program to address disparities in cancer clinical trials and the feasibility and utility of the pilot self-assessment for trial sites.5,6 Results from the self-assessment study found that most of the research sites in the pilot program (62 of 65) did not collect, or routinely collect, data for screening, offering, and counseling patients to clinical trials. Without this information, concluded the study authors, “sites are unable to evaluate and monitor whether their patients have equitable access to clinical trials or establish strategies to address any inequities.”5
The study assessing the implicit bias training program, which included eLearning modules that featured education on diversity, equity, and bias in clinical trial participation, found there was an increase in knowledge across all key training concepts, with an average percent increase from 19% to 45%. Similar increases were noted for strategies to address implicit bias, with an average percent increase from 10% to 31%.6
“There is a lot of work that needs to be done to create the infrastructure to successfully follow who goes on clinical trials,” said Lori J. Pierce, MD, FASTRO, FASCO, Board Chair of the Association for Clinical Oncology and Co-Chair of the ASCO-ACCC Steering Group and Professor Vice Provost for Academic and Faculty Affairs at the University of Michigan School of Medicine, Ann Arbor. “We at ASCO and ACCC want to work with these partners to understand how our organizations can help them create the infrastructure they need to improve clinical trial accrual. We will continue to work collaboratively to help practices utilize both the site assessment and the implicit bias training tools when they are released later this year. The pilot program is now completed, but we want to connect back with the 75 research sites to get a greater understanding of what they need to better track patients and their enrollment into clinical trials. That will be the next focus of our work.”
The ASCO Post talked with Dr. Pierce about the ASCO-ACCC collaboration and its potential impact on increasing participation of underrepresented racial and ethnic minorities in cancer treatment trials.
Mitigating Implicit Bias in Cancer Research
Please explain what the test site self-assessment and the implicit bias training in the pilot program entailed to address the barriers to clinical trial participation for minority patients with cancer.
The site self-assessment was designed to measure how an institution or oncology practice screens, enrolls, and retains patients in a clinical trial and to understand what infrastructure must be in place to accomplish the goals of bringing diverse patients onto a study and keeping them on the study. Based upon the answers we got from the research sites, we developed recommendations for specific strategies to improve the performance of each institution or practice to successfully enroll and retain patients in a study.
I say it like that because not all research programs are alike. You have large and small institutions and practices, and their barriers to trial enrollment, procedures, practices, and policies are going to vary. One institution’s strength may not be a strength in another institution, so each site had to do a deep dive from within to see what its policies and practices are and what the barriers are that need to be improved.
The pilot program was focused on Black and Hispanic/Latinx patients with cancer. However, when we release our data collection and evaluation participation metric tool to the general oncology community later this year, it will address the barriers to trial enrollment for all minorities underrepresented in cancer clinical trials.
“Although we need more racially and ethnically diverse oncologists, we also need more diverse members of the research team.”— Lori J. Pierce, MD, FASCO
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Regarding the implicit bias training, it is designed to understand, acknowledge, and mitigate implicit bias in cancer research. We know there is bias in all of us. We must understand the role that implicit bias plays in the lack of diversity in clinical trials. This training will help us recognize and mitigate implicit bias. The training is an online, self-directed program and includes interventional components, such as patient stories, and gives participants an opportunity to respond to case vignettes and examine their responses to address implicit bias.
The training is meant to raise awareness about how implicit bias contributes to a lack of diversity in cancer trial participation. I think with all of us, if you raise awareness of the problem, you can then correct the bias.
Matching Patients to an Appropriate Trial
There are many reasons why minority participation in research studies is so low, including patients are often not asked to enroll in cancer clinical trials and others are reluctant to join a trial because of fears of past medical experimentation. How can these obstacles be overcome, and what will progress look like?
I moderated an educational session at the 2022 ASCO Annual Meeting, “Overview of Barriers to Ensuring Racial and Ethnic Diversity in Clinical Trials” (https://meetings.asco.org/abstracts-presentations/203990/video), which looked at the obstacles for enrollment into clinical trials. One of the panelists, Mark E. Fleury, PhD, Principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network, made the key point that the largest barrier is patients are not matched with a trial.
When you peel the layers of the onion of why they are not matched, there are many reasons. One main reason is patients often are not asked to enroll in a cancer clinical trial. Besides the -ASCO-ACCC site assessment, we need implicit bias tools to understand and fix what is happening to prevent more minority patients from participating in clinical trials.
In a study by Joseph M. Unger, PhD, and his colleagues investigating the participation rate for patients actually offered a trial, they found that even with all of the trust issues, and all of the barriers, Black patients participated in clinical trials at similar rates as White patients, and that more than half of all patients with cancer offered a trial do participate.7 The results tell you that even though there are unique barriers, including trust issues, for certain populations, patients will go on a trial at the same rate, so we have to ask them.
As to how obstacles can be overcome and what progress will look like, trust is key. No matter who you are, you want to be able to have trust in your caregiver. There needs to be better communication and better interaction with minority communities, even when there is no specific cancer to be addressed per se. Cancer prevention is always a good subject of discussion. No matter who they are, people need to feel comfortable in seeking health care and in their interactions with the medical community.
I firmly believe communication is the key to overcoming trust obstacles, but oncologists must look at their own processes, find where the difficulties are, and bring more minority patients onto clinical trials.
Developing a More Diverse Oncology Workforce
Please talk about the importance of including diverse populations of patients in clinical trials to understand the effectiveness of innovative targeted drugs, immunotherapies, and cellular therapies in all patients with cancer.
The opportunity to go into a clinical trial represents the best treatment option for patients—and in some cases, the only treatment option. You must have diverse populations of patients in trials, so they have access to the best possible therapy, and we have a sense of what the efficacy and toxicity of that therapy will be in more diverse patient groups.
One of the factors to enrolling more diverse patients into clinical trials is having a more diverse workforce. Research has shown that racial and ethnic minority participation in trials is higher in centers with a diverse workforce. And although we need more racially and ethnically diverse oncologists, we also need more diverse members of the research team. For example, clinical trial navigators are so important in terms of patient education, and patients often gravitate toward patient navigators and not just the attending physician to better understand clinical trials. The whole issue of workforce diversity is so important not only for the oncologist, but also for the whole oncology team.
Improving the Clinical Trial Process for All Patients
Just 5% of adults with cancer of any race enroll in clinical trials. How hopeful are you that it will be possible to increase participation not just by minority patients, but by White patients as well?
I am very hopeful. The whole concept behind the site assessment was to understand where cancer centers and community practices can improve their clinical trial process in terms of patient enrollment and retention. And although they may have some issues that are specific to some groups more than others, looking inward to see where the barriers are will improve the process for all patients.
The ASCO-ACCC Pilot Project specifically focused on Black and Hispanic/Latinx patients because they are particularly underrepresented in adult cancer trials. However, understanding the depth of the barriers should have implications for the clinical trial process overall. I am very hopeful that by improving the process across the board, we will increase participation in research trials not just by minority patients, but by White patients as well.
DISCLOSURE: Dr. Pierce has stock and other ownership interests in PFS Genomics; receives royalties from UptoDate and PFS Genomics; and has uncompensated relationships with Bristol Myers Squibb and Exact Sciences.
REFERENCES
1. Unger JM et al: Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst 111:245-255, 2019.
2. Duma N et al: Representation of minorities and women in oncology clinical trials: Review of the past 14 years. JCO Oncol Pract 14:e1-e10, 2018.
3. Murthy VH et al: Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291:2720-2726, 2004.
4. Oyer RA et al: Increasing racial and ethnic diversity in cancer clinical trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement. J Clin Oncol 40:2163-2171, 2022.
5. Pressman AR et al: Availability of data for screening, offering, and consenting patients to cancer clinical trials: Report from an ASCO-ACCC collaboration. 2022 ASCO Annual Meeting. Abstract 6530. Presented June 1, 2022.
6. Barrett N et al: Assessing feasibility and utility of an implicit bias training program for addressing disparities in cancer clinical trial participation. 2022 ASCO Annual Meeting. Abstract e18599. Publication only.
7. Unger JM et al: ‘When offered to participate’: A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst 113:244-257, 2021.
