Mount Sinai team awarded grant to address racial disparities in cancer trial participation
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The issue of racial and ethnic disparities in health care has moved to the forefront of the medical community and has been further underscored by differences in COVID-19 vaccination rates.
In oncology, disparities in clinical trial participation between white patients and Black, Indigenous and people of color (BIPOC) have been especially stark. To better understand this longtime problem, Mount Sinai researchers have obtained a $6 million grant from Stand Up To Cancer to lead a team of New York institutions devoted to health equity in cancer research.
The SU2C Health Equity Breakthrough Team will be headed by Nina Bickell, MD, MPH, professor of population health science and policy at Icahn School of Medicine at Mount Sinai.
“One of our aims focuses directly on the community — the idea that we need to both understand and potentially change people’s views about clinical trials,” Bickell said in an interview with Healio. “Against the backdrop of COVID-19 it offers a great opportunity, because people are beginning to see the importance and impact of research.”
Healio spoke with Bickell about the causes of low clinical trial participation among historically underrepresented patients with cancer and discussed ways in which the collaborative effort will seek to engage these patients.
Healio: Why do BIPOC populations have lower rates of enrollment in cancer clinical trials?
Bickell: One major reason is that trials must be available and patients must be eligible. Patients need to be open to the idea of clinical trials and their relevance. Information about the trial needs to be communicated to the patient, and they must be able to participate without undue burden.
In terms of BIPOC patients being open to the idea, we know terrible things have been done to Black individuals in the name of “research.” So, there is an underlying mistrust. We see some of that playing out now in the differential uptake or receptiveness to the idea of COVID-19 vaccination.
Interestingly, several studies have shown that when approached about participating in a cancer clinical trial, Black patients and white patients have similar rates of acceptance. That means Black patients probably are not being approached regularly. Other studies in which researchers were interviewed as to why they thought BIPOC patients were not being approached have shown a good deal of implicit bias on the part of the providers. We need to start dealing with some of that implicit bias that gets in the way of a patient being offered the chance to participate in a trial.
Another major reason why so few BIPOC people end up enrolling in a trial is the presence of comorbid conditions such as hypertension and diabetes. These occur more commonly in BIPOC individuals and cause them to be excluded from trial participation. There needs to be a broadening of eligibility criteria. We built into this project a way of identifying gaps in trials to stimulate development of new research for patients for whom there are not existing trials.
Participants in a clinical trial also may face added expenses. There is parking, transportation and the need to coordinate with work. It helps to have a flexible work environment that will give you time off and will not penalize you. So, financial toxicity is also an important component. Part of what we built into DISRUPT (Diversity & IncluSion in Research Underpinning Prevention & Therapy trials) includes the clinical patient navigator, which will not only provide some of the education I mentioned but also will be helpful in steering patients toward services that can reduce some of these financial barriers.
Healio: How did you bring the team together?
Bickell: We built on the community outreach and engagement leadership of the cancer centers serving northern Manhattan and the Bronx, communities that experience some of the worse cancer outcomes in the nation. This was a collaboration across institutions — Columbia, Einstein, City College and Mount Sinai — and community partners. We met a few times a week for months to develop the ideas and approaches. It became clear from these discussions that being able to offer and ultimately recruit underserved populations to clinical trials requires intervention at multiple levels.
Oftentimes, especially in cancer, people don’t hear about clinical trials until they have exhausted all standards of treatment. So, clinical trials take on a negative connotation; people feel like they may as well try it because there’s nothing else left. So, we’ll talk with community members, get a handle on what people think, and then develop messaging and educational programs to modify the way they view clinical cancer trials.
Another goal is to target the research community. We want to make sure the general scientific community is aware of cancer health inequities. We want them to go back to their labs and come up with new or different ideas. Toward that, we’re developing a curriculum about health inequities in cancer to teach to bench scientists, undergraduates and graduate students.
Healio: What are your plans to “disrupt” the way in which the research community recruits patients to cancer clinical trials?
Bickell: In general, a principal investigator comes up with an idea for a trial and tells their research nurse to find patients eligible for that trial. We want to disrupt that approach. Rather than taking patients to the trials, we want to bring trials to the patients.
We are focused on three cancers — breast, prostate and liver — in which strong racial and ethnic disparities exist. We’re going to look for patients who are newly diagnosed or experiencing disease recurrence/progression and need treatment.
We will look through the electronic medical record and classify patients based on their cancer type, stage and receptor status. We will simultaneously look at the clinical trial data management software, which will include trial inclusion/exclusion criteria, to identify trials that may be applicable to these patients. These will include all open, relevant trials from the patient’s home institution, as well as from other participating institutions (Mount Sinai, Columbia and Einstein). We’ll take the list of clinical trials and the patient characteristics and create matches. We’ll send the match list to the patient’s oncologist the night before and during their visit. The goal of this is active education and to overcome implicit bias. We’ll also educate patients around clinical trials in general, and around that specific trial.
What we’ve learned from the community is that the reasons BIPOC people don’t join trials is multifactorial. So, our solutions have to be multifactorial. We will integrate what we learn, close all the loops, and maximize the chance for BIPOC patients to join a trial.
For more information:
Nina Bickell, MD, MPH, can be reached at 1 Gustave L. Levy Place, Box 1077, New York, NY 10029.
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