Presentation by Dr Arturo Loaiza-Bonilla, Capital Health Cancer Center, Co-Founder, Massive Bio
Cancer remains a leading cause of death worldwide, with 23.6 million new cases of cancer expected by the year 2030. Clinical research and drug development has resulted in impressive strides in treatment across many different cancer types such as breast and lung. Despite this, however, a significant, and now, an increasingly well-recognized problem our current system of clinical trials for cancer is a profound lack of adequate and diverse racial representation and participation. At the 2023 West Oncology Conference, Dr Arturo Loaiza-Bonilla from Capital Health Cancer Center and Co-Founder of Massive Bio, reviewed the current problem of racial representation and health equity in clinical trials and efforts to address the problem.
Current Disparities in Cancer
While there has been significant progress made to increase cancer specific survival overall, progress has not been uniformly observed across all racial groups. Cancer is the leading cause of death among Hispanics, surpassing cardiovascular disease and accidents which are second and third, respectively. There have been both favorable and unfavorable changes in some modifiable cancer risk factors in the United States, for example while smoking rates have decreased overall across racial groups, obesity rates have increased, and rates of obesity in Mexican Americans are higher in both men and women as compared as compared to their non-Hispanic White counterparts. Black Americans also have higher rates for selected cancers such as cancer of colon and rectum, as compared to their non-Hispanic White counterparts. Notably, rates of obesity are also higher among Black Americans, particularly Black females.
Clinical Research: The Gaps
Dr Loaiza-Bonilla reviewed some sobering data regarding diversity in clinical trial participation in the United States, with < 5% of adults having participated in any clinical trial, and more importantly 75% of those participants were White. As such, underrepresented populations, including Blacks and Hispanics, who, as noted above, may have higher incidences of some health problems including cancer, do not have access to the most effective and/or investigational treatments. This, in turn, serves to further compound the health disparities for the underrepresented. Moreover, if Black and Hispanic participants, for example, are largely underrepresented in a clinical trial, then that trial does not provide a scientifically accurate picture of the true efficacy and safety of the given treatment or intervention across a diverse patient population.
There are similarly sobering data in the setting of cancer clinical trials, with only 1 in 20 cancer patients overall having participated in a clinical trial, and the rates of enrollment for racial/ethnic minority populations having decreased over the past 14 years. He also reviewed data from a 2012 study showing that, while approximately one third of the US population is Black or Hispanic, only 17% of patients were of a racial or ethnic minority were enrolled in an industry-sponsored clinical trial. Another assessment found that Black participation reached 10% for only 2 of 31 cancer drugs that were studied. Data further suggest that clinical trial participants are most often non-Hispanic White men with higher incomes and educational levels. Data such as these clearly demonstrate the profound underrepresentation in cancer clinical trials of populations who need may need cancer treatments the most.
What are the Barriers to More Diverse Trials?
Dr Loaiza-Bonilla reviewed a number of barriers to more inclusive clinical trials in cancer, one of the most important of which is an overall lack of trust. In one study for example, nearly one third of Black women thought that scientists could not be trusted versus only 4% of White women. Such perceptions in the community may also be exacerbated by a lack of minority investigators involved in clinical research, emphasizing the importance of promoting diversity in the clinical workforce.
A general lack of knowledge and awareness also plays a role in the lack of diversity in clinical trial enrollment. In one study of Black women, nearly all participants reported that their doctor had never even spoken to them regarding the possibility for participating in a trial. This can be related in part to an inherent bias, for example, in considering patients of color or other ethnic groups, that the patient has too many struggles in their life to comply with clinical trial protocols, or that they may have a negative perception about clinical trials. While such perceptions may or may not be accurate, depending on the patient, Dr Loaiza-Bonilla suggests that we need to ask, to determine if any barriers to trial participation exist, and if so, are there ways they might be overcome.
The term “Social Determinants of Health” refers to a wide range of factors that can further impact a patient’s ability to participate in a clinical trial, such as socioeconomic status, language barriers, literacy, education level, neighborhood and physical environment, social support system, employment and financial issues, and overall access to health care. Logistics and costs of trial participation are another frequently cited concern that limits trial participation, particularly among racial/minority subgroups and those with lower income. Although study drugs, treatment, and costs for testing are often covered by a trial sponsor, there are a range of other logistical issues like cost of transportation/lodging/gas and time off work that must be considered, particularly for lower income participants. Another consideration that serves to hinder more thoughtful and diverse clinical trial enrollment is physician’s lack of time or experience in clinical trials, and a lack of institutional participation in clinical trials in the community setting.
Looking Toward Solutions
While the hurdles to achieving greater diversity in cancer clinical trials are many, Dr Loaiza-Bonilla believes there are viable solutions to the problem that can be implemented. Promoting a greater community involvement and outreach, with a focus on hiring not only more racially diverse physicians in the workforce, but also having a patient engagement staff that is more culturally concordant with the community (e.g., for Hispanic communities, Spanish language materials and Hispanic staff) can be helpful. Financial assistance programs that cover essential trial-related expenses like transportation can also help facilitate enrollment and participation. Tailoring education and support programs that more specifically target specific cultural backgrounds and literacy levels can also help overcome the problems of lack of knowledge and access. There is evidence that such educational and support programs can increase enrollment and maintenance on trial for underrepresented populations.
The community-based practice is an integral part of cancer treatment in the US, with 85% of the 1.7 million Americans diagnosed with cancer receiving care at such a center (as opposed to a large academic cancer center) in 2021. As noted above, costs of travel, time off work, etc. can be a major hurdle to patient’s trial participation, and in this regard, Dr Loaiza-Bonilla noted the still-to-be-enacted DIVERSE Trials Act (H.R. 5030/S.2706) which allows trial sponsors to cover ancillary costs of trial participation. Expanding major cancer trials to include community cancer centers can also be helpful to reduce travel/time off burden and enhance participation.
Dr Loaiza-Bonilla noted that major governing bodies in clinical research, such as the US Food and Drug Administration (FDA) have called for greater diversity and inclusiveness in clinical trial populations for over 35 years, and some proposed legislative initiatives would require trial sponsors to develop and submit diversity action plans aimed at achieving demographic equity in Phase III studies of novel therapies. The US FDA has also developed guidance for enhancing trial population diversity, which recommend that sponsors review study criteria carefully to ensure it is as inclusive as possible. Parameters to review in this regard include factors such as age, disease stage, gender, and ethnicity. There has also been a call to action to remove inclusion and exclusion criteria for clinical trials that may be too restrictive. One study found that eligibility requirements can disqualify 40% of cancer patients with a trial available to them, and this may be particularly restricting for Black trial participants who may be more likely to have comorbid conditions like cardiovascular disease.
Dr Loaiza-Bonilla noted a range of innovative clinical trial designs, made possible through the use of digital technologies which is also helping to remove barriers, such as time, location, and costs that can hinder trial participation in underserved community populations. For example, the decentralized trial does not rely on patients being in close proximity to one clinical trial site. The ‘just-in-time’ approach requires that patients come to a designated site only at specific times during the course of a trial. Dr Loaiza-Bonilla briefly described some existing technologies that help to facilitate participation and support for clinical trial participants, such as mobile cancer apps now being used by patients with some of the most common cancers such as breast, skin, lung, and prostate. The use of mobile devices, digital health and artificial intelligence (AI) approaches can also help to better match patients with an appropriate clinical trial.
Lastly, Dr Loaiza-Bonilla provided an example of how technology can be a facilitator to achieving greater representation and participation in clinical research, using a Deep-Learning Virtual Tumor Board (DLVTB) which can help to provide state-of-the-art cancer care to the majority of patients who receive care outside of an NCI-designated cancer center.¹ Utilizing the DLVTB approach in colorectal cancer patients showed benefits in potentially improving patient survival, reducing costs, recommending patients for additional testing, and recommending appropriate clinical trials in close proximity.
Summarizing, Dr Loaiza-Bonilla expressed optimism and the potential for using existing technologies to create an environment that encourages a more equitable representation for all racial and ethnic groups in cancer clinical trials. He encourages a more sensitive and patient-centric approach care to stimulate trust within our underserved communities and a careful assessment of our own preconceptions and biases that may exist which can hinder trial participation for all patients. He also noted the importance of maintaining an active engagement with the patient throughout the clinical trial process, to support them through symptoms and side effects that can occur. He also expects an expanded use of technologies such as artificial intelligence and “big data” approaches in the future, to facilitate greater participation, collaboration, and cooperation in clinical cancer research. Further reading on barriers to health equity in cancer trials by Dr Loaiza-Bonilla is also available.²
1. Available at: https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.e18635 Accessed: February 17, 2023.
2. Available at: https://www.pharmexec.com/view/health-equity-barriers-in-oncology-trials Accessed: February 17, 2023.
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