Clinical trials have an ugly history with race, but have we gone from exploitation to exclusion? People of color have long been underrepresented in clinical trials of all kinds; however, as the coronavirus pandemic rages and global attention is fixed on vaccine trials, the low participation rates of people of color have been noticed by the lay media. Much of the medical community would say that this is due to patients’ mistrust of research, but instead of focusing on individual factors, we should consider how we design our studies.
Diversity in clinical trials is important to ensure the efficacy and safety of a new treatment for people of all backgrounds. Many cancer experts believe that people of color have poorer cancer outcomes than white patients partially because most studies included predominately white patients. We owe it to our patients to ensure that approved treatments have been tested on a diverse sample as the efficacy may be different depending on the group. This is especially important for diseases like COVID-19, in which people of color are disproportionately affected.
But accrual of racial and ethnic minorities to clinical trials remains low, despite many outreach efforts. Many have posited that historical abuses are to blame by seeding well-earned mistrust in communities of color. To be sure, horrible things were done to people of color in the name of research: the Tuskegee experiment and the Henrietta Lacks tragedy are just the most famous of the many horrors committed. However, this perspective that historical abuses are the cause is limiting. Pinning the blame on researchers of the past absolves us of the responsibility for this disparity and has prevented us from looking critically at our own practices.
Historical abuses are cited by some patients as their reason for declining to participate in studies; however, as researchers studying this topic, we have spoken to hundreds of patients about this, and very few have mentioned past abuses. A lack of knowledge and access is a more likely barrier, as only 58 percent of Hispanic patients and 67 percent of black patients we spoke with knew what a clinical trial was in comparison to 93 percent of white patients.
While patient concerns about historical abuses that need to be respected, there are also structural issues at work here. Clinical trials are often conducted at large academic centers that patients who lack access to adequate transportation may not be able to reach. Trials often require a significant time commitment, which patients with inflexible working hours may not be able to undertake. Information about clinical trials is often full of complex medical jargon, which is difficult for many patients to understand. Also, many of our eligibility criteria are exclusionary. Nine percent of clinical trials registered with clinicaltrials.gov are only open to English-speaking patients; 31 percent of early-phase cancer clinical trials exclude people living with HIV, and 21 percent exclude people living with hepatitis B or C. All of these criteria disproportionately block people of color from participating in clinical trials.
While this issue is multifactorial, the structure of our studies plays a role, and is within our control to fix it. Researchers should make clinical trials more accessible by providing patients with simple explanations of studies at a variety of locations, including community clinics and medical centers. Increased flexibility regarding transportation and visit timing is essential. Researchers should also allow the participation of people who do not speak English and those living with chronic conditions whenever it is safe to do so. If the treatment will be approved to use on these populations, it is unethical to exclude them. These are considerations that researchers must think about not only when designing COVID-19 studies, but all clinical trials, as this is essential to reducing health care disparities overall. Moving forward, we must put fairness and our patients’ safety above increased cost or administrative burden; perhaps this is how we begin to make amends for the atrocities of the past.
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