Q&A: Increasing diverse patient enrollment and accrual in oncology clinical trials

Oncologists from The Oncology Institute of Hope and Innovation (TOI) discuss strategies for how they achieve non-white ethnicity patient enrollment in their clinical trial portfolio.
Authors Derrick J. Beech, MD, FACS
Senior Medical Director, TIME Program, Tempus

Paul La Porte, MD
Oncologist, TOI

Omkar Marathe, MD
Oncologist, TOI

Increasing the diversity of patients participating in clinical trials is key to advancing health equity based on the unique cultural, disease progression, and lived experience differences amongst these populations. Since 2007, The Oncology Institute of Hope and Innovation (TOI) has spearheaded these efforts by providing specialized, value-based oncology care at the community level. Comprising over 100+ diverse clinicians across five states, TOI aims to prioritize the diversity of patients enrolled in and accrued to oncology studies nationwide.

Dr. Derrick Beech, Senior Medical Director at Tempus with over 20 years of experience as an academic leader and surgical oncologist, recently sat down with Drs. Marathe and LaPorte from TOI and discussed key approaches clinical practices can take to increase the diversity of clinical trial enrollment and accrual.

What percent of TIME patients enrolled in your clinical trials are from minority ethnicities?

Dr. La Porte: When we look at TIME trials, 45% of patients who are enrolled are from non-white ethnicities1.

As you think about clinical trials, what are the barriers to access and participation in trials that are faced by patients from ethnically diverse backgrounds?

Dr. La Porte: One of the barriers we’ve observed at TOI relates to payor status and insurance coverage. Most of our patients are disproportionately from lower-income backgrounds, and are often recent immigrant arrivals. Many of these patients are beneficiaries of programs like Medi-Cal (California’s Medicaid program), which shepherd them into coverage through managed care organizations (MCOs). Patients covered under MCOs historically have limited access to networks that participate in clinical trials.

Transportation-wise, it’s often challenging for patients’ family members to accompany them to repeat visits scheduled closer together, say multiple times a week, compared to those farther apart, say once every two to three weeks. At TOI we have programs in place to address and remedy many of these barriers. Additionally, Tempus works closely with our team to ensure insurance or budget issues will never impact a patient’s ability to be considered for a trial.

Dr. Marathe: From a logistical standpoint, certain patients prefer not to travel to distant sites. However, our trials program strives to provide them with transportation for these visits. Another major issue we’ve experienced pertains to trial consent and accrual decision-making for some patient subgroups, where a patient’s participation in the clinical trial may ultimately depend on counsel from their family and on their family’s perception of it.

What characteristics about The Oncology Institute do you believe enable you to provide equitable clinical trial access to your patients?

Dr. La Porte: Assuming a clinical trial is available and a patient is eligible to participate in it, a crucial determinant of patient enrollment and accrual in that trial is whether a patient’s oncologist clearly explains the benefits and risks of patient participation. Based on the provider-patient relationship established during office visits, the patient’s primary oncologist is more likely to be the one to educate the patient on participation in the trial rather than another clinical trial staff member (such as a screener who cold calls patients) with whom the patient does not have an existing relationship. Since we have a largely ethnically diverse, economically disadvantaged patient population—typically underrepresented in clinical trials—they are more likely to trust providers with whom the patients have close, trusting relationships developed during ongoing counseling and conversations about viable treatment options.

Dr. Marathe: Our clinical trials team at TOI—especially the providers—is culturally competent and sensitive to providing inclusive, unbiased, culturally appropriate care for the different cultures and groups. Each accrual to a trial occurs following extensive communication between patients and their respective provider. For instance, I explain to my patients why a clinical trial may be a better fit for them than current standard-of-care options, as well as a review of associated trial risks. During these conversations, I also typically discuss the consent forms with the patients and their families, after which they can take copies to review and discuss with the families at home. Additionally, I emphasize to patients that we’re recommending these trial options in their best interest but, ultimately, their voluntary consent is required to proceed with the trials.

TOI has a diverse staff, including PIs. You also have Tempus Clinical Research Coordinators through the TIME program. What impact do you think these factors have as it relates to clinical trial enrollment?

Dr. Marathe: Our staff, plus the Tempus Clinical Research Coordinators, work together to impact clinical trial enrollment. Our staff, starting with the trial coordinators, nurses, or doctors, are from diverse backgrounds. We believe that this contributes to patients trusting us when we explain clinical trial options or consent them to these trials.

Tempus Clinical Research Coordinators augment our team, and are able to provide heightened support for screening, enrollment, and clinical trial visit activities. Tempus employs Clinical Research Coordinators and provides them to TOI for the purpose of pre-screening patients for yet to be activated TIME Trials. If and when a TIME Trial is activated at TOI, a Tempus CRC can perform certain activities under the study provided that the site reimburses Tempus for those services.

We also find it is important that the provider that has been engaged in the patient’s treatment, explain the trial to both the patient and the family. Beyond speaking the same language with these diverse patient populations, our consent forms are translated into Spanish and other languages, depending on the disease prevalence in specific populations.

Dr. La Porte: Compared to clinics in racially homogenous regions of the United States, the racial diversity of patients who receive care at TOI’s campus in California is reflected in its staff. Interestingly, this diversity varies from the categories NCI considers traditionally under-represented in clinical trials. For instance, there are immigrants from South America, East Asia, and Eastern Europe. Having providers from diverse ethnic and cultural backgrounds increases the likelihood of patient enrollment and accrual in clinical trials.

How would you evaluate the areas of success and opportunity you see for The Oncology Institute as it relates to equitable clinical trial enrollment?

Dr. La Porte: Unlike other oncology practices, TOI partners heavily with MCOs, especially those who offer patients coverage under Medi-Cal, employer-sponsored Medicare Advantage Commercial plans, and Covered California plans (also known as the Affordable Care Act). Doing so means we automatically provide care to patients disproportionately from ethnic minority backgrounds, and a largely Medicaid population typically excluded from participating in clinical trials. TOI has full support from our MCO partners to screen covered patients for clinical trials. As our internal processes provide equal opportunity for inclusion in our clinical trials, these patients are offered the benefits of clinical trials as an option.

Additionally, partnering with companies like Tempus, which offer financial assistance for patients unable to afford the copays for diagnostic workup services like next-generation sequencing, streamlines the process for referring patients to trials for which they are eligible2. For instance, without sequencing data, it can be challenging to determine whether a patient should enroll in a trial treating a specific type of cancer resistance mutation. These coverage options enable more equitable clinical trial enrollment for patients who are underinsured or have no insurance at all.

Dr. Marathe: Partnering with Tempus offers the patients at TOI opportunities to access
targeted precision medicine services, regardless of their ethnic background or socioeconomic status. Doing so opens up previously inaccessible access points to participating in clinical trials with promising and highly innovative cancer medicines.

How do just-in-time models like TIME help increase trial access in a meaningful way for your patients?

Dr. La Porte: Yes, the just-in-time model is a smarter and more efficient way of helping our patients gain access to clinical trials. With a master agreement in place to provide access to a portfolio of clinical studies, accrual is easier across multiple trial sites because the terms for patient participation in the trials are pre-determined, eliminating the need to activate each study site by site.

1. As of 12/1/2023

2. Sequencing with Tempus is not required to participate in the TIME program.

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