Expert Offers Ways to Reduce Disparities in Cancer Clinical Trials

Racial and ethnic disparities in cancer clinical trials has a pressing challenge that not only impacts diagnostics and treatment of minority populations, but also raises the question of whether trial results are truly applicable across all populations, according to Ruben Mesa, MD.

“[Diversity in trials] is really essential. It's not an extra; it's not a sub-focus; it's not something where a couple of people at your institution can work on health disparities. Almost all of us work in diverse communities and our advances in how we care for cancer in all populations depends on those trials being accurate and learning from those populations,” stressed Mesa. “For us to do that, the patients on our studies have to really reflect our population. This is essential in terms of the accuracy of studies, as well as the public good, and, of course, being an important resource for all these individuals from these communities.”

As an institution based in San Antonio, a city in which 64.2% of the population are Hispanic and Latino,¹ UT Health San Antonio MD Anderson Cancer is 1 of many institutions that are working to move the needle forward by encouraging more diversity in cancer clinical trials. By tailoring clinical trials to meet the needs of, and to reflect, the local population, investigators hope to produce results are more widely applicable to the real-world population seen in practice.

“[Strategies] need to be individualized,” Mesa explained. “We need to be mindful of the community. A whole variety of parallel strategies as they relate to eligibility, access, feasibility, participation, transportation, health disparities, good informed consent, and support for not only enrolling on the study, but being able to stay on the study [are all needed].”

In an interview with Oncology Nursing News' sister publication, OncLive, Mesa, the director of UT Health San Antonio MD Anderson Cancer Center, discussed racial and ethnic disparities in cancer clinical trials and efforts that are being made to address these issues.

OncLive: Could we start off by discussing why it's so important to include a racially and ethnically diverse patient population in clinical cancer trials?

Mesa: Clinical trials are how we really improve the treatment of cancer, whether it be about developing new therapies, new modalities, testing, radiation therapies, or surgery. In order for those trials to really inform us and improve cancer care for everyone, those trials have to our population—the actual people we are treating. In addition to all of the important issues related to social justice and those individuals having access to those studies, the results are only really valid if they reflect the actual patients who are being treated.

Speaking to your specialty, do you feel that a lack of diversity impacts clinical trials focused on myeloproliferative neoplasms (MPNs)?

As it relates to those myeloid illnesses, our trials have suffered from the same challenges in terms of diversity, as have trials in solid cancers and others. Many factors contribute to this, including trial access, having the economic means to participate, corresponding expenses to participate, employment barriers, and even awareness in health literacy. Also, the concentration of those studies is often at academic centers that have more limited geographic distribution, which means that patients have to travel there. Many drivers [result in decreased participation]. Because of that, we have less confidence that the outcomes we see [from these trials] are as applicable across all populations as we wish that they would be.

On a more local level, San Antonio, Texas, the city in which your institution is based, has a significant Hispanic and Latino population. Do you feel that this patient subgroup is getting an acceptable level of representation on local clinical trials?

I would say both yes and no. In addition to [working with patients with] myeloid diseases, I'm the director of our National Cancer Institute (NCI)—designated Mays Cancer Center at the University of Texas Health San Antonio MD Anderson Cancer Center. Having trials being representative of our population is an important part of our mandate. Our region is San Antonio and South Texas, which is around 69% Hispanic or Latino. We accrue well over 50% Hispanic [patients] onto our cancer clinical trials, as well as an overrepresentation in terms of other minority groups, such as African Americans. We're close to representing our population, but it isn't 100%. This is something that we focus on and consider for every trial that we open—from the consent process to the design of the study, to the barriers that we are hoping to overcome.

I think that we do a pretty good job of providing that access in our most immediate region of San Antonio. Where I feel we continue to have opportunities [for improvement] is [reaching those] individuals who live in deep South Texas along the Rio Grande Valley. For many of them, awareness [of available trials] and transportation capabilities [are big challenges]; our center or other centers are typically hundreds of miles away. I'm hopeful that as we continue to leverage telemedicine, that may be a strategy that could assist us in overcoming some of these barriers.

What are some other approaches that might help to address this issue?

I would start at the national level. This is something that is well-recognized as an area of importance with mandates and strategies both being encouraged and developed at the NCI and with our colleagues in the pharmaceutical industry; I participate in a committee that helps to advance this at Genentech Pharmaceutical, which is made up of external advisors on this process including Bristol-Meyer Squibb and others.

At my [institution], the Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, we both work with the Cancer Prevention and Research Institute of Texas (CPRIT) in our efforts across the state of Texas along with our UT system partners MD Anderson and many others.

The strategies are multifold. One, it's around trial eligibility; are there built-in barriers to participation, as it relates to kidney function, renal function, mild disorders of the metabolic syndrome, etc? Are there issues related to access? Are there issues related to the frequency of visits for the trial? Is it much more challenging for someone who is an hourly worker to participate compared with someone who has a job that is much more accommodating in terms of being away from work?

We're also very mindful of language barriers and genuine informed consent. Many populations exist within the Hispanic community, and they all of different aspects of different cultures; I, myself, am Cuban. Here, in South Texas, it's a very family-oriented community, and in families, there is typically a health expert. If the grandmother of the family, [for example], has cancer, and her nephew who is a pharmacist is the designated family health expert, if he is not involved with the discussion and the informed consent process, there's no way she's going to participate in the study or be aware of how it might be helpful.

There are a variety of best practices that continue to be evolved around the cancer community and us sharing those and learning from some of the strategies that work in certain populations versus others are incredibly important.

How can cancer centers work to improve their clinical cancer trials to be more cognizant of diversity?

The key is how we try to weave these principles into our studies. Some studies certainly have health disparities as the focus, and those are very important, as they help to identify barriers and how we can overcome them. However, the way to think about this is not by making it a study on health disparities, but instead, taking that trial on breast cancer, colon cancer, or acute myeloid leukemia, and helping it to reflect the actual population that's out there. How do we overcome those barriers so that trials really represent our population, so that those results can really be applicable?

Is there anything else that you would like to add?

I think the key for this is really teamwork. We're at a moment in our national conversation regarding the importance of diversity of our society on many levels, and this is just 1 aspect of that. Again, [combined efforts of] stakeholders from the FDA, from the pharmaceutical industry, from the medical community and academic centers, from third-party payers, and patient advocacy groups [are all needed]; accomplishing this isn't going to be easy. It is always easier to follow the path of least resistance. Unfortunately, that path ends up developing data from clinical trials that aren't really broadly applicable.

For example, I study myelofibrosis, and we performed a trial where we had sites in China. What we learned was that there were aspects of the disease that were different in China. Not only was the trial evaluating the efficacy of the drug, but we made insights into causes of anemia in that particular disease because of differences in how the disease affected the 2 populations. The point is that many important discoveries can be made. We may find the cure for cancer based on differences between populations. It's going to take teamwork for us to accomplish this.

Reference

QuickFacts: San Antonio city, Texas. United States Census Bureau. July 1, 2019. Accessed August 5, 2020. https://bit.ly/3gGO7v3.

Read more: Data Breakdowns May Uncover More Cancer Disparities

This article was originally published on OncLive as, "Mesa Sheds Light on Strategies to Combat Racial/Ethnic Disparities in Cancer Clinical Trials."