Over the last week, people across the US, and part of the UK, have come out in great force to protest the death of George Floyd, a black man murdered whilst held in the custody of a white police officer. The protests, that were started in the streets of Minneapolis and have now spanned the globe via social media, send a clear and powerful message against police brutality of BAME (Black, Asian, and Minority ethnic) individuals that confronts the silence surrounding systemic racism. As the world re-evaluates their own conscious and unconscious prejudice, it is absolutely vital that, especially as we are amid a global pandemic, the medical industry does the same.
The fact is that BAME individuals are, right now, at a higher risk of dying from COVID-19 than their white counterparts. By the end of May, the COVID-19 mortality rate for Black Americans (1 in 1,850) was 2.4 times as high as the rate for white Americans (1 in 4,400). This same report estimates that, if they had died of COVID-19 at the rate of white Americans, around 13,000 black Americans, 1,300 Latino Americans and 300 Asian Americans would still be alive today.
In the UK, the situation is not any better - in fact, in many areas, it is far worse. The first statistics concerning the spread of the virus, released back in April, reported that around 33% of patients in intensive care were BAME; and these numbers are strikingly disproportionate when we consider that the groups make up only around 14% of the population. Not only this, according to the Office for National Statistics, black men in the UK are 4.2 times more likely to die from the coronavirus than their white counterparts.
So, what exactly does all this mean for the medical industry? In the past, it’s been so easy for us to look the other way and label it “a political issue”, “not our responsibility” or “beyond our control”. Now, however, the situation has changed. New evidence suggests that there is a strong correlation between representation in clinical trials and the health of minority groups. According to a recent report by the US Food and Drug Administration (FDA), only 4% of cancer clinical trial participants are black, 4% are Hispanic, and 15% are Asian. Yet, last year, the American Cancer Society reported a near-equal rate of incidence in both white and black patients. This ultimately means that the black population is severely under-represented in trials to cure an illness that affects them just as much as white Americans.
With studies showing that certain peoples can respond to the same medical therapy very differently, a lack of diversity is not only damaging from a moral perspective, but it may also have potentially dangerous, undocumented results on part of the population. Today, we take a look at the two key lessons clinical research today has learned from the George Floyd protests, and what targets need to be fulfilled by every clinical trial that is running or restarting in our more socially-aware world.
Educate the masses
Much like what is happening on social media with black awareness at the moment, the industry must act as thought-leaders in clinical trial education. It is documented by the FDA in a recent post that minority populations may lack the core knowledge about clinical research opportunities, which, in turn, contributes to lower rates of representation in trials. Yet, education on clinical trials should not just be for certain groups - it must be for all. In fact, a recent survey by Clinical Leader found that two-thirds of all respondents didn’t know whom clinical trials are targeted at, with high levels of stigma surrounding the topic of medical research overall.
It is now the responsibility of the researcher to educate the population by advertising their studies in ways that appeal to the general public. The path to enlightenment is an essential part of any strong, feasibility analysis. (Check out our top tip for managing your feasibilities here.) Use the numbers and statistics redundant in your humanitarian pledge to outline your ideal candidate and relinquish any misconceptions. Share, retweet, or regram to let people know if they can get involved. In short, focus your early efforts on advertising and, by doing so, spreading awareness. At the end of the day, any researcher's goal should be to make participation in clinical studies the accepted, the norm, and the "for me."
Meet diversity quotas
The thing about clinical research, that makes the industry so universal, is that it should be available for all. Back in March of this year, Stand Up to Cancer (SU2C) taught us all a little something about the importance of diversity quotas as they announced their plans to address a lack of diversity among cancer research.
The company has brought in an initiative that will now require companies looking for SU2C-supported grants to up their game on meeting diversity quotas. Applications will now call for three new components all concerning health equity:
A summary of who will benefit among the population from their research;
A detailed patient recruitment and retention plan that is inclusive to historically underrepresented groups; and
A letter of approval from the institution’s Chief Diversity Officer, or someone of an equivalent position.
In addition, SU2C also upped their funding for the group’s Health Equity Research Breakthrough Team by up to $6.4 million. CEO Sung Poblete made clear that the changes were to ensure minority representation across cancer clinical trials is addressed:
“We are confident that this initiative will make a significant and meaningful impact to ensure all communities have equal access to potentially life-saving treatments.”
In short, trials everywhere must set and meet quotas on diversity. We need to educate potential patients on their eligibility for trials and provide our studies with ethical codes of conduct that place importance on ethnicity and look to combat systemic racism at a grassroots level. Failing this, all research sites must at least remember that a lack of diversity means inconclusive research, and inconclusive clinical research means FDA disapproval.
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