It is well established that Covid-19, at least in the United States, has disproportionately affected others of color. However, clinical trials of remedies and vaccines opposing Covid-19 have so far failed to recruit diverse populations that in fact reflect society.
Hala Borno is an oncologist at the University of California, San Francisco. He studied the gap between real-world demographics and clinical trial recruitment. He recently used STAT’s podcast, “The Readout LOUD,” to discuss the diversity and inclusion factor in Covid-19 clinical trials.
This transcript has been modified for clarity.
He has just co-authored a publication in Contemporary Clinical Trials Communications, which examines the racial and ethnic makeup of Covid-19 trials and compares it to what we know about the actual burden of disease in the United States. What did you notice in this investigation?
We reviewed published studies that, in particular, tested the effects of the Covid-19 remedy among affected populations. And we then looked to take a look at the studies they were recruiting in the United States. Of the studies we identified, 50% were observational, therefore real, analyses of covid-19 remedies and effects for patients. And 50% were randomized clinical trials, i.e. prospective efficacy trials. And what we observed was amazing.
A third of the studies reported knowledge about race or ethnicity. An examination even gathered racial knowledge among the participants. And we also observed that black patients were underrepresented in all studies regarding the disease burden among the black communities where these studies were conducted.
So when you step back and think about these results, you see that today, in 2020, in the context of a terrible pandemic that has highlighted racial and ethnic disparities in the United States, however, researchers do not collect or uniformly report knowledge about race and ethnicity in clinical studies published to treat the disease that disproportionately overwhelms racial or ethnic minorities. And it’s outrageous.
The knowledge we have noticed about Covid-19 vaccines is no greater in terms of racial and ethnic diversity. What is the threat if clinical trial proponents do not recruit populations that reflect the truth of Covid-19?
When you take a step back and think about what clinical studies are looking to do, try to expand empirical evidence that the intervention is effective. But not only that, you will also have to demonstrate empirical evidence that the intervention is safe. And when you do not recruit patients for clinical studies who will eventually get this procedure in the genuine world, then you will possibly lose a vital sign of efficacy or a vital sign of toxicity, which can also be devastating.
I believe that if we do not make sure of the diversity of these clinical studies on Covid-19, we may nevertheless carry out interventions, whether medicines or vaccines, that do not demonstrate uniform efficacy among populations or have side effects. that we won’t capture until later.
Some other people from underrepresented populations, especially blacks and Native Americans, distrust the medical status quo because of a long history of injustice. How can researchers build accept as true in communities that have had bad reports in the past with medical research?
This question arises: is there an inherited source of mistrust? Is there any contribution to fears of experimentation? I think it is vital to think about these elements when thinking about recruitment for clinical trials, especially among racial and ethnic minorities. But at the end of the day, there is a lot of evidence that shows that racial and ethnic minorities in particular … have shown a strong interest in participating in clinical studies when they were proposed and, in fact, have fairly high rates of acceptance of clinical studies when opportunities must be held for them. Array.. We will have to recognize that our history of exploitation in experimental studies is horrible and we will have to be informed of it. But it does not deserve to be prevented from providing clinical study opportunities to diverse populations.
We have heard from many drug brands and government fitness agencies about the importance of involving diverse populations in large-scale Covid-19 studies being conducted or planned by the end of this year. Is there any way to hold them accountable for those promises?
That’s a vital question. When you think about duty for a disease that affects everyone, it’s hard to think of an external tariff strategy. In the United States, we have had secure mandates to publicize diversity and inclusion. For example, the NIH Revitalization Act of 1993 mandated the inclusion of women and racial and ethnic minorities in publicly funded clinical trials. However, this command has not resulted in a transparent protocol or rules on how to achieve this.
The truth is, it’s hard to hold investigators to account. But I think one thing is crucial: at the very least, we make sure that they constantly collect racial knowledge and report on racial knowledge as they provide the knowledge and effects of their interventions.
Outside Covid-19, many of his paintings are aimed at participating in cancer clinical trials among racial and ethnic minorities. Has there been any progress in this global area that can point the way forward?
Yes, I think there have been many other methods that have been promising. When you think about recruitment, there are two main categories to consider. One is an awareness-raising strategy: what is the strategy in communities that can promote diversity and inclusion in clinical trials? And then, what is the strategy within the sites that recruit patients for clinical trials? This is the internal strategy and there are other interventions in any of the categories.
For example, at the University of California, San Francisco, where I exercise, I work with the Lazarex Cancer Foundation to establish a monetary reimbursement program for cancer patients who enroll in clinical cure trials. It is a strategy to reduce some of the indirect prices related to participation in clinical studies to ensure that the most monetaryly vulnerable patients can enroll in clinical trials and not withstand the blows of this participation.
There are other strategies, but they want to adapt to the disorders you isolate, either by recruiting patients for your site or simply making sure you’re testing the diversity you see on your site.
This is a modified transcript of a recent episode of STAT’s biotechnology podcast, “The Readout LOUD”. I like that? Remember to subscribe to pay attention to each episode.
Coronavirus
Health disparities