By Allison M. Whelan*
The COVID-19 pandemic has given renewed importance and urgency to the need for racial and gender diversity in clinical trials.
The underrepresentation of women in clinical research throughout history is a well-recognized problem, particularly for pregnant women. This stems, in part, from paternalism, a lack of respect for women’s autonomy, and concerns about women’s “vulnerability.” It harms women’s health as well as their dignity.
Over the years, FDA rules and guidance have helped narrow these gaps, and recent data suggest that women’s enrollment in clinical trials that were used to support new drug approvals was equal to or greater than men’s enrollment. Nevertheless, there is still progress to be made, especially for pregnant women. In the context of COVID-19 research, one review of 371 interventional trials found that 75.8% of drug trials declared pregnancy as an exclusion criteria, a concerning statistic given that recent data suggest that contracting COVID-19 during pregnancy may increase the risk of preterm birth.
But if we probe further, we see that not all women are treated equally in the context of medical research. Rather than being viewed as needing protection, women of color have long been subjected to unethical and exploitative medical experiments and procedures. This spans from experimentation during human enslavement carried out by doctors like James Marion Sims who, although often touted as “the father of modern gynecology,” abused and terrorized Black women with excruciatingly painful gynecological procedures; to Henrietta Lacks, whose cells were taken without her consent and continue to be sold and used in the development of countless medical advancements; to recent allegations of medical abuse and forced sterilizations of women held at an immigration detention center in Georgia.
Excluding women from clinical trials is problematic, but including a subset of women in ways that are unethical, exploitative, and harmful is just as problematic, if not more so. There are many potential consequences, including a hesitancy to enroll in research and distrust in the medical products developed through research.
This has particular import during the COVID-19 pandemic because of the disproportionate number of cases, hospitalizations, and deaths among people of color. And although FDA has been adamant that it “will not cut corners” when reviewing COVID-19 products such as vaccines, there is significant concern about whether the U.S. population, particularly people of color, will be willing to get vaccinated. For example, one study found that only 17% of Black adults would “definitely get” vaccinated, compared to 37% of white adults. And another poll found that only 14% of Black Americans and 34% of Latinx Americans mostly or completely trust that a vaccine will be safe.
Scholars have long documented such distrust and its many consequences. Thus, these concerns are not new—even though they seem to be systemically undervalued and ineffectively addressed.
Until we better address and mitigate the consequences of history, a problematic cycle will continue—trials will be inadequately diverse, people of color will question whether they are being used as “guinea pigs” and whether medical products are safe and effective for their communities, and health care disparities will remain.
The COVID-19 pandemic provides a prime opportunity to reignite important discussions and the search for solutions. The political and social atmosphere in which the development of COVID-19 drugs is taking place has undermined Americans’ trust in the process, particularly among people of color. Myriad factors play a role in whether, and to what extent, people of color feel they can trust COVID-19 research, treatments, vaccines, and the government’s overall response to the pandemic, all of which must be addressed to defeat COVID-19 and the many other health care disparities plaguing our nation.
Where do we go from here? These issues do not have a single cause and thus cannot have a single solution. Any solution must be multifaceted and include changes that target clinical trials specifically, as well as much broader societal changes. A few ideas, discussed in greater detail in a forthcoming issue of the Cornell Law Review, include:
- Statutory and regulatory mandates.
- FDA guidance/policy.
- Private and public funding/monetary incentives to support and reward outreach, education, and recruitment/enrollment of diverse clinical trial populations.
- Greater transparency and de-politicization of the drug approval process.
- Broader societal/structural changes.
The COVID-19 pandemic has shined a brighter light on already-known disparities in medicine, such as access to and enrollment in clinical trials and trust in medicine, and has given renewed importance and urgency to these issues. This article has barely scratched the surface of the significance of these issues and potential solutions to consider. These issues are not new, but the COVID-19 pandemic has made them all the more salient. Distrust in medicine and the government will make it difficult, if not impossible, to defeat this virus. There is thus no time like the present to revisit these issues with a renewed sense of passion, purpose, and urgency.
*Allison M. Whelan, J.D., M.A., is an attorney at Covington & Burling LLP, Washington D.C. The views expressed in this article are the author’s own and do not represent those of any past, present, or future employer.