A blog post by Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D.
The first clinical trials for a potential COVID-19 vaccine began last month in Seattle, where 45 young, healthy adults were enrolled in a phase 1 study. With the pressure on to develop vaccines and treatments, other trials will be launched as quickly as possible.
In the understandable rush to respond to the novel coronavirus/COVID-19 pandemic, it’s important to adhere to tried and true research practices that produce valid scientific results. These practices include enrolling diverse groups of participants in clinical trials to make sure new vaccines and medicines work well for people of all ages, genders, races, and ethnicities.
Vaccines play an essential role in public health, especially in protecting the most vulnerable. Early experiences with COVID-19 indicate that vulnerable populations include the elderly and those with underlying health conditions and compromised immune systems.
Those who are economically disadvantaged also are likely to be at higher risk. Regardless of age, many of them have underlying health conditions, in part because they cannot easily access health care. Many are underinsured and live in communities where quality medical care is unavailable. This lack of routine medical and preventive care can have a lasting negative impact on health and quality of life.
According to 2018 U.S. Census data, Native Americans (25.4%), black Americans (20.8%), and Hispanic Americans (17.6%) are more likely to live in poverty than white (10.1%) or Asian Americans (also 10.1%). Income and health disparities tend to go hand in hand.
Ensuring fair representation in clinical trials is one of many steps we can—and must—take to reduce disparities and advance health equity. It is critical that members of minority populations be enrolled in all clinical trials related to COVID-19. Excluding minorities will exacerbate U.S. health disparities by creating yet another condition where treatments are either less available to certain populations early on or less effective for them over the long term.
Everyone benefits when treatments work well for all populations. That should be a goal of all clinical trials, including those for COVID-19 investigational vaccines and treatments. Only then can we be confident that all populations are equally protected against future outbreaks.
Marjorie A. Speers, Ph.D., is an epidemiologist and global leader in human research protections. Before taking the helm at Clinical Research Pathways, Dr. Speers was the founding president and CEO of the Association for the Accreditation of Human Research Protection Programs. At the Centers for Disease Control and Prevention, she was the deputy associate director for science and oversaw research protections for domestic and international research.