Black Patients in COVID-19 Clinical Trials: Moving Beyond Mistrust
Centuries of structural racism and racial health inequities have manifested as a high burden of COVID-19 related hospitalization, severe illness and death for Black patients. After months of politicization of safety measures such as mask wearing, unmerited attacks on science in lieu of a coordinated national pandemic response, and a death toll nearing 140,000 Americans, a safe and effective vaccine can’t get here fast enough. Thankfully, initial phase I data from the first COVID-19 vaccine tested in the U.S. are promising. The vaccine, mRNA-1273, produced the anticipated immune response in all of its 45 volunteers without any safety concerns and the research team is moving forward with a phase 3 clinical trial.
Researchers have pointed to a moral and ethical obligation to ensure that the populations disproportionately harmed by COVID-19 are included in therapeutic and vaccine clinical trials. Despite this, there were only 2 Black participants in the mRNA-1273 study.
So where are all the Black people?
Failure to include underrepresented minorities is unfortunately commonplace in research. For instance, over 80% of genome-wide association studies are based on individuals of European descent. Epidemiology research often uses large registries that historically lack racial and ethnic diversity. COVID-19 therapeutic trials have inconsistently report race and ethnicity data — the remdesivir for instance published participant racial and ethnic demographics, but the dexamethasone trial did not. Where race data are available, it is clear that Black and Latinx are not enrolled as study participants reflecting the large issue underrepresentation of minorities in nearly every domain of therapeutic clinical trials except those for which the requirement for informed consent is waived.
It is customary for researchers to cite Black patient mistrust in health care when discussing racial inequities — tracing hesitation to enroll in clinical research to anti-Black transgressions such as the Tuskegee Syphilis study. Yet, when public health officials declare the importance of rebuilding trust, they repeatedly forsake the opportunity to acknowledge the complex ways second-class social designation and racism have and continue to harm Black bodies in healthcare interactions.
Public health officials, clinicians and researchers must begin the march towards equity in COVID-19 study enrollment with a sincere disavowal of the systems of power and structural contexts that have permitted anti-Blackness in medicine. This means, our goal is not to blame individuals for making the rational calculation to be suspicious of clinical trial offerings from a healthcare system that undertreats Black pain, delays mammogram follow-up for Black women, overperforms undesirable interventions such as castration and amputation and permits disproportionately high rates of Black maternal mortality. Rather, with an understanding of the historical and contemporary ways that Black people are mistreated even when undergoing non-experimental interventions, we approach the table of reconciliation with empathy ready to tear down and rebuild the systems and structures that have led us here.
With such an approach, we imagine that improved enrollment of underrepresented minorities in COVID-19 clinical trials will require committing to a system that reflects a general commitment to racial equity. Such a system would do the following:
1. Accept that it’s a patient’s prerogative to decline clinical trial participation. We must refrain from asserting what Black people and other minority groups should do. Placing a value judgement on a patient’s decision to enroll or decline participation in a clinical trial centers the interests of the medical research community and endangers autonomy. Patients may feel their decision to decline participation may jeopardize their care or relationship with their provider. Ethically, a provider’s motive should be to provide adequate accurate information to facilitate a patient’s personal decision, not to coerce participation by provoking guilt.
2. Ensures that there are well publicized community and institutional safeguards against enrollee exploitation. Despite the existence of the office of human research protections and institutional review boards, patients belonging to groups that have been repeatedly harmed are owed additional assurances and transparency regarding how they will be protected in all stages of clinical investigation. Communication with respected community stakeholders and inclusion of community representatives on institutional review boards and data oversight committees is one approach to ensure that the process is patient-centered, transparent and well publicized.
3. Rely on standardized information campaigns to educate potential participants about trials for which they may be eligible or potentially derive benefit. Providers may avoid discussing clinical trials based on misinformed assumptions about patient’s willingness to participate. Having an unbiased service that informs patients about trials that are available, the study objectives, and the reasonable expectations for potential benefit would, at least in part, override some of the physician bias that leaves many patients uninformed about available clinical studies.
4. Recognize that the system of capitalism perpetuates value distinctions among racial groups and therefore has no place in an equitable healthcare system. This would mean supporting the elimination of for-profit elements of medical care and pharmaceutical company price gouging, in favor of a system where individuals receive care based on need. A single-payer system would ensure that individuals were able to afford the standard of care components of clinical trials. While eliminating profit incentives would ensure that vaccinations were prioritized for the most vulnerable rather than for the wealthy.
5. Alleviate the burden of clinical trial participation by providing social support. The economic disparities that promote the overrepresentation in minimum wage jobs, ensures reliance on public transportation, maintains higher rates of under or uninsured create practical barriers to clinical trial participation for Black people. The mRNA-1273 trial required no less than 8 separate visits for sample collection. A patient without the financial means to support multiple days of transportation to a medical facility, time away from work and child-care arrangements will find it particularly burdensome to manage the frequent visits. The medical community should therefore lobby employers for job protection and adequate leave and provide transportation and child-care provisions to support trial participation
This may seem an indirect approach to addressing diversity in COVID-19 clinical trials. Yet, the multifaceted manifestations of racism in clinical medicine and research have caused this lack of diversity, particularly the absence of Black patients. The fix, therefore, requires more than simply putting a bandage over the festering wound we call mistrust. If our desire to restore Black patient’s faith in medical professionals and institutions is sincere, we must target the racism that has long rotted our healthcare system. In doing so, we not only improve participation in clinical trials, but also begin on a path towards equity in COVID-19 treatment and outcomes.
