Nationwide Initiative Aims to Address Disparities in Early-Phase Cancer Clinical Trials

Access to early-phase cancer clinical trials can often be limited due to patients’ socioeconomic status or their location, creating a barrier of entry for diverse and medically underserved populations who are frequently not enrolled onto early-phase studies.

To expand access to cancer care and research, Stand Up To Cancer® (SU2C) has launched a 4-team initiative across the United States designed to fill in these gaps in care and remove barriers to entry. The overarching goal of the program is to address cancer disparities and facilitate the development of new treatments that have the potential to benefit patients and may be replicable across other institutions.

The 4 teams include:

• Martin Edelman, MD, and Linda Fleisher, PhD, MPH, who will focus their initiative on accelerating and diversifying access to clinical trials at the Fox Chase Cancer Center
• Anthony B. El-Khoueiry, MD, and Chanita Hughes-Halbert, PhD, who will lead their initiative on eliminating enrollment barriers to early phase trials in diverse populations within Los Angeles County at the University of Southern California (USC) Norris Comprehensive Cancer Center.
• David Gerber, MD, and Chika Nwachukwu, MD, PhD, who will translate their efforts in transferring care to enhance access to early-phase cancer clinical trials at University of Texas (UT) Southwestern Medical Center, in Dallas.
• Walter M. Stadler, MD, and Briseis Aschebrook-Kilfoy, PhD, who will aim to enhance diversity in early phase clinical trials in an urban underserved community at UChicago Medicine

Edelman is the chair of and a professor in the Department of Hematology/Oncology, the deputy cancer center director for Clinical Research, and G. Morris Dorrance Jr. Chair in Medical Oncology at Fox Chase Cancer Center, Temple Health, and Fleisher is an associate research professor of Health Communications and Health Disparities, a co-director of GMaP Region 4, at Fox Chase Cancer Center, and a co-lead at National Cancer Institute’s (NCI) Cancer Center Cessation Initiative. El-Khoueiry is an associate professor of clinical medicine in the Division of Medical Oncology, a member of the Gastrointestinal Cancers Program, a director of the phase I drug development clinical program, and medical director of the Clinical Investigations Support Office, at USC Norris Comprehensive Cancer Center, and Hughes-Halbert is the associate director of Cancer Equity, a professor, and vice chair of research in the Department of Population and Public Health Sciences, at USC Norris Comprehensive Cancer Center.

Gerber is a professor of internal medicine and a co-director of the Experimental Therapeutics Program at UT Southwestern Medical Center, Simmons Cancer Center, and Nwachukwu is the associate program director of Medical Residency at Simmons Cancer Center and an assistant professor of radiation oncology at UT Southwestern Medical Center. Stadler is the Fred C. Buffett Professor of Medicine, the deputy director of the Comprehensive Cancer Center, and the dean for Clinical Research at the University of Chicago Medicine, and Aschebrook-Kilfoy is an associate professor of public health sciences in the Department Public Health Sciences at the University of Chicago.

In a series of interviews with OncLive^®, Edelman, Fleisher, El-Khoueiry, Hughes-Halbert, Gerber, Nwachukwu, and Stadler detail their involvements with SU2C’s initiative of better serving underrepresented populations and increasing diversity in early-phase clinical trials.

Accelerating and Diversifying Access to Clinical Trials

Edelman: The Fox Chase Cancer Center is part of the Temple University Health System, and part of our mission within the larger health system is to improve the care of [patients with] cancer. Fundamental to that are clinical trials and clinical research. One of our major sites, which has been a long-term site for us where we've done a lot of prevention work, has been Temple University Hospital, located in north Philadelphia, serving a minority and economically insecure population.

When [the SU2C] opportunity became available, I saw this as an opportunity for us to expand our infrastructure at Temple University Hospital, where we already had plans in place to expand the clinical investigator faculty. We already had some infrastructure that was there. However, this became the catalyst for clinical research at Temple University Hospital and throughout our system. As that system grows, [it] impacts a large population in north Philadelphia and southeastern Pennsylvania.

Fleisher: We are extremely excited being 1 of 4 sites nationally to be involved in this [SU2C] initiative. In addition to what Dr Edelman said, this brings a multidisciplinary team together as a part of this grant where we have multiple physicians with different specialties, [including] palliative care and our community outreach and engagement core. It has been an opportunity to bring many components of our institution together, [with people] who have expertise in different areas around clinical trials so we can address [diversity in clinical trials] in a comprehensive and holistic way.

It has been an exciting opportunity for us to do this, and I'm looking forward to learning from the other sites that are also part of this initiative. We're all dealing with this in different ways and looking at different strategies. We'll be able to share those [strategies] beyond the scope of these four initiatives.

Eliminating Enrollment Barriers to Early Phase Trials in a Diverse Population in Los Angeles County

El-Khoueiry: We are thrilled about being part of this [SU2C] initiative, which is really unique. We're thankful for SU2C and the sponsor, Janssen Pharmaceuticals, who partnered with SU2C to fund this. We are 1 of 4 teams that were awarded [a grant] through this initiative. The focus is increasing diversity in early-phase trials. What I appreciate is that this focus on diversity in early phase trials is a very targeted initiative. We and other teams bring different resources, ideas, and initiatives to the table.

Our initiative is based in Los Angeles [LA] County, and it is focused on the concept that we have the Department of Health Services in LA County, which has safety-net hospitals. This includes the LA County USC Medical Center, Harbor-UCLA Medical Center, and the Olive View-UCLA Medical Center. There is this series of safety-net hospitals that serve many patients who belong to minority or underrepresented groups. The idea here is to leverage our experience at USC, where we have established a clinical trial infrastructure including early-phase trials, and we want to extend that opportunity to other safety-net hospitals within this network.

In our proposal, we will work closely with Harbor-UCLA at multiple levels to reduce or remove many of these barriers [to clinical trials] and facilitate referrals from Harbor-UCLA for our early-phase trials. We will also work with Olive View , which will serve as our control. We will not do active interventions at Olive View, which will allow us to measure how effective the interventions are and if they make a difference.

Hughes-Halbert: This program is a key component of SU2C’s health equity initiative, and we're excited to be part of that. I sit on the steering committee for health equity within SU2C and know that this is work that is deeply ingrained across many issues. We're delighted to be part of the effort and to have the support.

Transferring Care to Enhance Access to Early-phase Cancer Clinical Trials

Gerber: [There are] 3 main areas that we need to think about when it comes to access to trials: eligibility criteria, trial-required procedures, and trial availability. We have decided to focus on trial availability for our project because it seems like something that is underappreciated and understudied. It is something where we think we can make a real impact.

Let's think for a moment about how early-phase clinical trials work. These are generally more complicated clinical trials than later-phase studies. They may have additional procedures, [such as] repeated blood draws over several hours on multiple visits to check the levels of drugs or pharmacokinetics. They may have extra biopsies and special research scans. Only a small proportion of clinical centers can conduct such studies. They have the extra staff, extra space, and extra resources and time to do it.

One type of facility that might have a particularly difficult time [conducting an early-phase trial] is a public hospital or a safety-net health-care system. There are a lot of examples of safety-net health care system around the country. We have Parkland Health in Dallas, Texas, which is our integrated safety-net health-care system. It is difficult for any of these centers to activate and conduct early-phase clinical trials because these are centers that have an obligation to provide the best cancer care to as many patients as possible. When you think about all the additional effort that goes into an early-phase trial, it may be difficult to fit that within your general operations or your prioritization, especially during the COVID-19 [pandemic], when some of these hospitals had up to 50% of their beds filled with individuals [infected with COVID-19].

The second thing we have to remember about cancer clinical trials in the United States is that they're very different in one main way from other types of clinical trials done in the United States and cancer trials done in other countries. That's the fact that the clinical trials themselves, their budgets usually don't cover all the costs of caring for the patient when they're on a trial. If a patient goes on a typical trial, [perhaps for] an oral cardiology drug or a mental health condition, the trial often pays for everything for the patient. Any patient who meets eligibility and is able to get to a center could go anywhere for treatment [on these types of clinical trials]. However, cancer clinical trials oftentimes can't afford to pay for everything because a trial might add a new drug onto existing therapies that could cost hundreds of thousands of dollars per year. So we depend on insurance to cover the usual parts of care. If a patient doesn't have insurance, they may not be able to go to a place that otherwise has early-phase cancer clinical trials that depend on insurance to pay for the costs of care for that patient.

One of the reasons that we see a lot of enrollments to cancer clinical trials in Eastern Europe, Asia, and areas where patients don't frequently have high levels of medical insurance is because outside of the United States, it's more likely to see trials complete everything in their budgets. However, when you put all this together in the United States, we have to figure out a way [to improve access to these trials]. If we can't do the early-phase trials in the safety-net settings where we see diverse populations, we cannot automatically tell those individuals to go anywhere to get on an early-phase trial if they don't have their own insurance or way to pay for the standard-of-care component of their treatment. We have got to come up with a system to bridge that gap, and that is what we are trying to do.

Nwachukwu: Parkland Health has a patient population that is underrepresented. About 70% of the patients are underrepresented minorities. Simmons Cancer Center at UT Southwestern and the oncology department of Parkland are [essentially] staffed by the same physicians, so physicians at UT Southwestern also take care of patients at Parkland.

Another thing that we know is that transfer of care is very feasible. We have experience with it, [and] we have done it in the radiation oncology department. Parkland itself does not have its own radiation facility, so Parkland patients who require radiation are transferred from Parkland to UT Southwestern. One reason why this is completely feasible is because of the proximity of the 2 cancer centers. They are less than a mile apart from each other. We are able to treat a significant proportion of underrepresented patients who have varying cancer diagnoses. We already have a system in place that is tried and true, so we know that this is feasible.

In addition, we have support systems already [in place] at Parkland. Things that we have in place include bilingual clinical research navigators that helped patients through the Parkland system and we are modeling the same system at UT Southwestern. That will help our program and make our program a little bit more successful. Patient navigators will help with care coordination, help with psychosocial support, and address logistical barriers.

To ensure we have the broadest impact on diverse populations, there are similar relationships between Parkland and UT Southwestern, [as well as] other safety-net systems and cancer centers are across the country, specifically NCI-designated cancer centers. If our model works, it's a model that could easily be transferred to other [health-care] systems to ensure that the need for the population that requires these early-phase clinical trials is being met.

Finally, we have seen that there is a growing number of pharmaceutical companies that are interested in providing a lot of care and optimal care for patients who need it, regardless of their financial status. All of these mechanisms [could] allow us to be able to reach the population of patients who need this [support] the most.

Enhancing Diversity in Early-Phase Clinical Trials in an Urban Underserved Community

Stadler: In addition to some of the physician-oriented barriers to trials, many people have discussed the patient/community barrier to participating in trials. This includes everything from health literacy to understanding of what clinical trials might be to distrust between the community we are serving and the physicians and medical centers that are providing the clinical trials and treatment services.

What we are interested in doing and why we are partnering with SU2C is to ask a simple question: does informing the physician and is working with the physician sufficient [enough] for enhancing accrual to clinical trials? Or do we also need to address some of these community- and patient-oriented issues?

Reference

Stand Up To Cancer announces four teams focused on diversity in early phase cancer clinical trials. News Release. Stand Up To Cancer. February 8, 2023. Accessed March 17, 2023. https://standuptocancer.org/press/