‘Call to action’: Head and neck cancer trials in US becoming less diverse
Key takeaways:
- The study revealed a lack of equitable representation in trials of head and neck cancer.
- Oncologists can help by ensuring that all their patients are screened for clinical trial eligibility.
Despite focused efforts to improve the diversity of clinical trials, representation in research into head and neck cancer has become less equitable over the past decade, according to retrospective study results.
Researchers from Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center reviewed data from head and neck cancer trials published on ClinicalTrials.gov with start dates between 2000 and 2023. Investigators assessed demographic data for 8,998 trial enrollees for potential demographic changes.
Over the course of 20 years, the proportion of white participants increased by 6.1%, the proportion of Black participants increased by 0.8% and the proportion of Asian participants declined by 3.1%.
“In many ways, our study is a call to action,” Melani Camryn Zuckerman, a fourth-year medical student at Boston Medical Center, told Healio. “It’s a statement that what we have been doing has not been working to improve diversity in our clinical trials. We want the people running these trials — and clinicians — to ask what has been going wrong and what we can be doing on every level to work to improve access.”
Healio spoke with Zuckerman and senior author Heather Ann Edwards, MD, FACS, FRCSC, associate professor of otolaryngology-head and neck surgery at Boston Medical Center, about the rationale for the study, the implications of the findings and what can be done to address this inequity in cancer research.
Healio: What motivated you to conduct your study?
Zuckerman: We’ve known for a few decades that cancer clinical trials have not been diverse. When trials are not adequately diverse, it can be difficult to apply the results to the populations that haven’t been studied. We also know that head and neck cancer, specifically, has different outcomes based on racial profile.
Edwards: One example is that Black Americans are less likely to survive a head and neck cancer compared with white Americans. This is a pre-existing piece of knowledge that was, in part, what motivated us to evaluate this.
Healio: How did you conduct this study and what did you find?
Zuckerman: We used ClinicalTrials.gov to evaluate the diversity of people who enrolled in every head and neck cancer trial between 2000 and 2023. When we compared 2013 to 2023 — the last 10 years of the study — we expected to see diversity improve, given all of the great initiatives that have been started. However, we were surprised to find that diversity was worsening over time. Additionally, when we compared the general population of patients with head and neck cancer to the study populations, the study populations were not representative of the patient population with head and neck cancer in the United States.
Healio: Why do you think the trend has gotten worse despite considerable efforts to improve trial diversity?
Edwards: Our study was not intended to answer that question. However, if we speculate, one reason may be that clinical trials in oncology are getting more expensive and more difficult to perform. There are more regulatory requirements, and the therapies can be very expensive. This can lead trial sponsors to work with historically successful centers who have shown they are able to mobilize these kinds of resources instead of smaller centers or less-established clinical trial programs. This tends to result in persistence of the status quo.
Another factor is how we measure success. Historically, when we talk about centers that are successful at conducting clinical trials, we’re basically talking about two things: how many patients they accrue, and how quickly they accrue those patients. Even though we talk about increased racial and ethnic representation as our goal, we often don’t “put our money where our mouth is.” We don’t really talk about that as a metric of success.
Healio: What are the potential implications of your findings?
Zuckerman: We are looking at using the data we’ve already compiled from ClinicalTrials.gov to identify future directions. We’re looking at which studies were more representative , trying to identify the reasons why those studies were successful, and seeing if there is anything other institutions can do to emulate the diversity achieved by those specific trials.
Healio: What can oncologists and other members of the cancer care team do to improve clinical trial diversity?
Edwards: I recommend clinicians do two things. First is to make sure every patient is screened for clinical trial candidacy. This is something many centers have as a goal, but it takes resources, but ensuring equitable screening for every patient who comes into your office is the first step.
My second recommendation is to analyze screening logs. Every year, you should look at your screening logs and consider why people were excluded from enrolling. You can learn so much from doing this.
On a national level, I go back to the idea that if we want to improve representation in clinical trials, it takes investment. We know if we want to enroll populations from historically underrepresented backgrounds, it requires resources.
Reference:
For more information:
Heather Ann Edwards, MD, FACS, FRCSC, can be reached at heather.edwards@bmc.org.
Melani Camryn Zuckerman can be reached at mczucker@bu.edu.
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