It’s been well-established that Covid-19, at least in the United States, has disproportionately affected people of color. And yet clinical trials of treatments and vaccines for Covid-19 have so far failed to enroll diverse populations that actually reflect society.
Hala Borno is an oncologist at the University of California, San Francisco. She’s been studying the gap between real-world demographics and clinical trial enrollment. She recently called into STAT’s podcast, “The Readout LOUD,” to discuss the issue of diversity and inclusion in Covid-19 clinical trials.
This transcript has been lightly edited for clarity.
You just co-authored a study in Contemporary Clinical Trials Communications, looking at the racial and ethnic makeup of Covid-19 trials and comparing it to what we know about the actual burden of disease in the U.S. What did you find out in that research?
We looked at the studies that were published that specifically were examining the effects of a Covid-19 treatment among affected populations. And we wanted to look at the studies that were recruiting from the United States. Among the studies we identified, 50% were observational, so real-world analyses of Covid-19 treatments and patient outcomes. And 50% were randomized clinical trials, so prospective trials looking at efficacy. And what we observed was striking.
A third of the studies did not report race or ethnicity data. One study did not even collect race data among participants. And we also observed that Black patients were underrepresented in all studies relative to the burden of disease among the Black communities in which these studies took place.
So when you step back and you think about these findings, we observe that today, in the year 2020, in the context of a horrific pandemic that has shone the spotlight on racial-ethnic disparities in the United States, still, investigators are not uniformly collecting or reporting race-ethnicity data in published clinical research to treat the disease that is disproportionately burdening racial or ethnic minorities. And that is outrageous.
The data that we’ve seen so far on Covid-19 vaccines isn’t any better in terms of racial and ethnic diversity. What’s at risk if clinical trial sponsors don’t enroll populations that reflect the reality of Covid-19?
When you step back and think about what is clinical research trying to do, it’s trying to develop empiric evidence that the intervention is effective. But not only that, it also has to demonstrate empiric evidence that the intervention is safe. And when you do not recruit patients to the clinical studies that are ultimately going to receive this intervention in the real world, then you may miss an important signal of efficacy or an important signal of toxicity, which could be devastating.
I think that if we do not ensure diversity in these Covid-19 clinical research studies, we may ultimately render interventions, whether it be drug or vaccines, that do not uniformly demonstrate efficacy across populations, or have side effects that we only capture later on.
Some people from underrepresented populations, particularly Black people and Native Americans, distrust the medical establishment because of a long history of injustice. How can investigators build trust in communities that have had previous bad experiences with medical research?
This issue always comes up: Is there a contribution of hereditary mistrust? Is there a contribution of fears of experimentation? I think it’s important to think about those components when you think about recruitment to clinical trials, especially among racial-ethnic minorities. But the bottom line is, there’s been a lot of data that show that racial-ethnic minorities specifically … have shown a great interest to participate in clinical research when offered and actually have pretty high rates of acceptance to clinical research when offered opportunities. … We should acknowledge our history of exploitation in experimental research is horrific and we should learn lessons from it. But we should not prevent it from offering diverse populations opportunities for clinical research.
We’ve heard a lot of drug manufacturers and government health agencies talk about the importance of enrolling diverse populations in the large-scale Covid-19 studies that are underway right now or planned for later this year. Is there a way to hold them accountable for those promises?
That’s a really important question. When you think about accountability for a disease that is affecting the entire world, it’s really hard to think through an international strategy for accountability. In the United States, we have had certain mandates to promote diversity and inclusion. For example, the 1993 NIH Revitalization Act mandated the inclusion of women and racial-ethnic minorities in publicly funded clinical trials. However, this mandate did not really come out with a clear protocol or guidance into how to achieve this.
The reality is it’s challenging to hold investigators accountable. But I think one thing is, is crucial: At a minimum, we should ensure that they are collecting race data uniformly and reporting race data as they present the data and the outcomes of their interventions.
Outside Covid-19, a lot of your work is focused on improving participation in cancer clinical trials among racial and ethnic minorities. Has there been progress in that world that might point to a way forward?
Yeah, I think there have been a lot of different strategies that have shown promise. When you think about recruitment, there are two major buckets to think through. One is an outreach strategy: What is the strategy out in the communities that can promote diversity and inclusion in clinical trials? And then what is the strategy within sites that are recruiting patients to clinical trials? That is the inner reach strategy and there are different interventions in both categories.
For example, at the University of California, San Francisco, where I practice, I work with the Lazarex Cancer Foundation to help deliver a financial reimbursement program for cancer patients enrolling in therapeutic clinical trials. That is a strategy to help reduce some of the indirect costs associated with participating in clinical research in order to ensure that the most financially vulnerable patients can enroll into clinical trials and don’t bear the greatest financial burdens of that participation.
There are different strategies, but they need to be tailored to the problems that you’re isolating, whether it be getting diverse patients to your site to recruit or just ensuring the diversity that you’re seeing at your site is getting on trials.
This is a lightly edited transcript from a recent episode of STAT’s biotech podcast, “The Readout LOUD.” Like it? Consider subscribing to hear every episode.
Interesting piece, but it would have added value to discuss what evidence there is for racial variations in drug efficacy and harms. My understanding is that race is overwhelmingly a social construct with very little biological basis, in which case trial participants’ race (as opposed to e.g. sex or age) should not be an important factor. Did I get that wrong?
The need for racial diversity has more to with including groups that have underlying health issues that are contributing the health disparities caused by the virus than any racial differences in response to the vaccine.
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