Thousands of clinical trials are run in cancer research every year to test new treatments and gather data about their effectiveness. But these studies can lack a diversity of participants, new research has indicated.
For example, Dr. Heather Ann Edwards, an associate professor of otolaryngology-head & neck surgery at the Boston University Chobanian & Avedisian School of Medicine, found in a new study that over time, diversity in head and neck cancer clinical trials has decreased. This is bad news, because several studies have shown that survival rates for cancer are significantly lower for patients of color when compared with white patients. One potentially influencing factor may be a lack of research focused on these populations and how these patients respond to new treatments.
Sampan interviewed Dr. Edwards about her research, its implications, and ways that researchers at Boston Medical Center, where Dr. Edwards serves as director of the head and neck surgery program, have worked to improve gaps in equitability in cancer research.
Sampan: Could you describe the research that you have done on the lack of diversity in cancer clinical trials and some of the results you have found?
Edwards: We have known that diversity in clinical trials in oncology has been a problem for a long time. This is a problem because we develop new treatments and new drugs in clinical trials. If the patients that enroll in clinical trials are different than the patients that we actually use those treatments on later, then we are giving patients treatments that were not shown to be effective in patients like them… There have been a lot of efforts at the level of the National Institutes of Health and the Food and Drug Administration to try to make clinical trials more accessible to diverse populations. What we wanted to look at was if these initiatives had been successful over time. We decided to look at all the clinical trials listed on clinicaltrials.gov, which is a large national repository.… We wanted to see if clinical trials were becoming more diverse or more representative over time. Going into the study, my hypothesis was that we would see improvement, but that it would not have reached equity. We were surprised that we found that, at least in the head and neck oncology space, clinical trials are becoming less diverse over time.
Sampan: I think that my interpretation was that awareness of the lack of diversity in research studies would increase over time, and yet you found the opposite has been happening in the enrollment of these studies. Do you have any potential hypotheses as to why there might be an increase in the lack of diversity over time?
Edwards: Yeah, I think that’s a great point. I do think, as you said, awareness is increasing.… So why is it still getting worse, even though there’s more awareness of it? Our study did not address the why, but I do, just as someone who has an interest or expertise in this space, I do have some hypotheses. I think one of the reasons is that clinical trials are actually getting more and more expensive to perform over time with increased regulatory requirements and the increased cost of treatments like immunotherapy drugs.… The groups that pay for clinical trials are often predisposed to do them in centers that have an established track record in being effective at running clinical trials. Therefore, they tend to center their trials at these big established cancer centers as opposed to doing them in smaller communities which may have more diverse patient populations.
Secondly, I think that within the world of clinical trial research, we have historically considered the markers of success as the number of patients you accrue and how quickly you accrue them… Diversity is not something that is considered as a marker of success… I think that as long as people are not putting money behind it, people may be talking about it, without actually having financial incentives to activate initiatives to improve it.
Sampan: What has been done by researchers to lessen this gap? I know that you work at BMC, which historically serves an underrepresented patient population. How have studies at BMC worked to ensure the patient population they draw from is representative of the patient population they serve?
Edwards: This is an area that we have done a lot of work on, and it is really important to us as a safety net hospital that our diverse patients have equitable access to clinical trials… Roughly 70% of our patients self-identify as people of color. We have a regimented process to ensure that every patient with head and neck cancer gets equitable consideration for clinical trials… What that does is that it removes some gatekeeper biases, such as if the person in the clinic happens to think of the clinical trial while seeing that patient – it formalizes the assessment. Another thing we do is periodically analyze our screening logs. Whenever you are running a clinical trial, you have a screening log where you record every patient that was considered for the clinical trial, whether they ultimately enrolled in it, and if they didn’t, why. Periodically analyzing our screening logs allows us to see what our local barriers are to enrollment. For example, we once found that a number of patients could not enroll in clinical trials because they did not have access to translated clinical trial documents in their language… That gives us a way to advocate for our patients and gives our sponsors a tangible thing they can do.
