Diverse Enrollment in Clinical Trials is Crucial to Address Disparities and Improve Cancer Care

Ruben A. Mesa, MD

Clinical trials represent a key opportunity for patients with cancer to receive treatment with a potentially life-saving therapy that may not be available to them otherwise. However, several barriers may hinder access to these research efforts, according to Ruben A. Mesa, MD, who added that increasing awareness of existing disparities, encouraging collaboration across the care continuum, and strengthening eligibility criteria, can all serve to improve outcomes.

“Even if you are not in 1 of those groups that is underrepresented, there may be discoveries that are directly relevant to you and your cancer that are equally relevant to others,” Mesa explained. “We learn from the totality of the experience, [and if] we have good representation across clinical trials, [we will see] better resource utilization, [develop] a better understanding of therapy and its targets, and [the] cancers involved. We all benefit [from this].”

In an interview with OncLive^®, Mesa, the executive director of Mays Cancer Center at UT Health San Antonio, discussed the different disparities that are known to affect cancer care and key efforts being made to address them.

OncLive^®: What are some of the specific disparities that currently affect cancer care?

Mesa: [Disparities affect patient care] on multiple levels, and there are several areas that we recognize. Disparities [can exist] in terms of social determinants of health, in areas of persistent poverty, with [regard to] access to care whether it be in rural or in underserved areas, due to preconceived biases from healthcare providers and systems, and [they can also exist] across race, ethnicity, and other ways [in which] people are divided.

In cancer, [disparities] can manifest in many ways. First, [they occur] in [terms of prevention]. We know there is a range of [factors] that can lead to great disparities in terms of higher rates of cancer amongst individuals, whether it is tobacco use, higher rates of obesity, or exposures to agents that can be harmful to us.

Disparities can be related to genetic factors, related to race and ethnicity; [for example, we know that] diseases like multiple myeloma can be overrepresented in African Americans. In south Texas, we identified increased rates of hepatocellular carcinoma [that are] highly disproportionate. We still do not fully understand [the reasons for this, but it] may be related to higher rates of fatty liver or other [factors].

Health disparities [affect] rates of screening [for cancer], access to screening, [delays in] screening, [and the amount of] primary care and core healthcare that could sometimes help to identify cancers earlier so they may be more amenable to surgical resection or curative therapies.

Health disparities [also exist in relation] to receiving cancer care itself; [this can include] access to clinical trials and barriers that exist with clinical trial participation, health disparities that relate to having good, quality information in a language [that patients] understand, or barriers that relate to health literacy, both [in terms of] language andcultural [challenges]. Health disparities as they relate to good post-therapy care [exist], whether it be [related to] supportive care, survivorship care plans, risk of long-term toxicities, orrisk of relapse. [The causes of these disparities] are multifaceted, but as it relates to cancer, there are many areas of opportunity [to address these].

What role do community engagement partnerships and collaborative efforts play in addressing these existing disparities in cancer care?

Community-based efforts are essential. They have been identified at the National Cancer Institute [NCI] as a critical piece [to this puzzle], and [it is necessary for] NCI-designated cancer centers to have community outreach and engagement [as] an essential [component] of their efforts. [Community-based efforts] are multifaceted; [they are centered] in public awareness and advocacy, as it relates to areas where we know contribute to cancer.

For example, [those at Mays Cancer Center] were active in trying to pass legislation, or advocate for the passage of a tobacco plan for individuals to have to [older than] the age of 21 [years]. We know that can be deeply impactful. We are also actively involved with many efforts to [improve] public awareness with regard to obesity and other key factors that [we know] can increase rates of cancer. Engagement with many groups, whether it be around diseases, churches for connecting with African American patients, the general public, or key organizations, [is impactful].

In our community, our University Health System, which is a safety net system that has an extensive primary care system, and CentroMed, which is another extensive primary care–type effort for the underserved, are critical partners. We know that an important step in [all of this] is [first] identifying [the cancer], whether it be through screening or [detecting] early signs [such as] pain, blood loss, or lumps, [so we can provide] timely care. Sometimes the delivery of cancer care, both within our city and region, involves partnership with many others in the cancer [community] including organizations or groups, [so that we have the] resources to care for the underserved. It takes a village, which is why this [concerted collaboration] has become a very important strategy for the war on cancer.

You participated in a Diversity in Oncology series, which is a virtual platform designed to raise awareness about the inequalities facing diverse patients with cancer. How has this series helped raise awareness faced by underserved communities, as they relate to care?

There are many facets to diversity in oncology. First, we recognize that [addressing some of these issues will involve] the next generation of cancer care providers, nurses, and scientists. Many ongoing efforts are trying to increase engagement so that the individuals involved in cancer care and research look like the communities that [they] are caring for. This broadens awareness, creates engagement, and helps to create trust between the healthcare system and these groups. Efforts [are also being made] to increase faculty [in terms of] cancer care providers and researchers, as well as leaders in efforts [being made] to expand [engagement].

[Several efforts are being made] to overcome barriers as they relate to cancer prevention, screening, and treatment. In particular, the ability to participate in clinical trials, not only treatment-based studies, but in prevention, screening, and survivorship-based studies [is important]. We [want to make] trials more reasonable in terms of eligibility criteria. Historically, [some eligibility criteria [were] inadvertently biased; [this included] complex schedules [that] were difficult for individuals to comply with. Barriers in terms of transportation and frequency of visits were sometimes onerous for patients, as well.

Newer methods for making participation more feasible [for these patients have been developed]. One positive [thing to come out of] the COVID-19 pandemic has been a rapid evolution of telemedicine and a [more] practical assessment of clinical trials to make them more feasible [for patients to participate]; we want to try to have them meet patients where they are. [These efforts] will continue to evolve, [with the goal of having] cancer trials be a bit more decentralized to make it easier for patients to enroll, participate, and benefit from [these research efforts] across the spectrum.

What were some of the key lessons learned from the series?

We tried to dissect [these] issues from [all angles]. What are some of [existing] barriers? How are those health disparities having a negative impact on cancer? [We took] a deeper dive into issues with clinical trials. How do we help modify these trials to make more feasible, and what are the other pieces [we should be aware of in terms of] health literacy?

It was discussed that we need to create better awareness in communities and help to demystify the clinical trial process. [Sometimes the] individual [patient] is either unaware or [has] a negative predisposition toward clinical trials when they are discussed with their healthcare provider; [this patient’s] likelihood of participating [on a trial] is much lower. How do we set the stage for patients to participate [despite] that [predisposition]?

Many lessons were shared. For example, at our center, we have recognized that particularly with Latino patients in San Antonio and south Texas, the ability to engage their family, loved ones, and their family healthcare expert in the discussion of treatment planning and where a clinical trial fits in is critical. Both pieces are essential. If we bring in the family and the healthcare expert only to discuss a clinical trial, it is only part of the equation. We must present them with all [available] options in a way that the patient, [and their close circle], can [understand] the whole discussion. Then, we frame how a clinical trial fits into that range of options so that they can make an [informed] decision that is supported by high-quality, well-translated materials. [They need to] have an appropriate informed consent process, and their family healthcare expert [should] be a part of that.

It takes a lot of teamwork. Sometimes it takes creativity, navigation, and transportation support. Sometimes it takes calling their employer to explain that they are going to be participating in a trial, if the patient wishes, to [help them to] overcome some of the barriers that they face.

[We had] a great discussion. We [approached this topic] from various angles as it relates to the Philadelphia area and some lessons learned from Fox Chase [Cancer Center], Boston University, [Mays Cancer Center], and the Thomas Jefferson Cancer Center. [We discussed] different experiences, but some shared challenges, and [it was] a great conversation on lessons learned.

What is your take-home message on the importance of diversity in clinical trial enrollment?

This is important; people in our society [must] have access to effective cancer care, and the ability to participate in cancer clinical trials is a critical piece of that. Participating in cancer clinical trials is not a luxury; it sometimes can be a lifesaving opportunity [for patients] to be able to benefit from the evolving therapies that are [under investigation].

The second [point that should be made], and particularly to address the skeptics out there [who ask whether] there is too much effort being placed on [inclusion in clinical trials], is that this is good science. It is critical that the participation in clinical trials reflects our society. We are [all] different, and we may respond differently [to treatment], whether it be [in terms of] effectiveness or toxicity. [We need to learn] from those differences to improve outcomes for everyone.