Scientific Experts from both the U.S. and Puerto Rico recently completed a new stud revealing the great need for diversity in vaccine clinical trials. Finding a decade of disparity, the authors published recently in JAMA Network Open and among other things found that in research across America not surprisingly Blacks, Latinos, Native Americans/Alaska Native represent the most “underrepresented groups.” Interestingly, adult women are now “overrepresented.” What did the study authors find? Based on an investigation into 230 U.S.-based clinical trials testing vaccines, covering all phases and 220,000 participants, the team found that from July 2011 to June 2020 that first and foremost many sponsors failed to even report on demographic data. Among the study’s that did report that, Whites accounted for 78% of all participants while women represented 56% of all participants. Blacks accounted for 11% of the total (not far off the total U.S. 12.%); Hispanics accounted for 12%, Native Americans/Alaska Native at 0.4% and individuals 65 and up accounted for 12%.
Recently, Fred Hutch released news on this topic as associate professor in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center. Dr. Steve Pergam served as one of the corresponding authors. Dr. Pergam shared that, “The COVID-19 pandemic and its devastating impact, particularly only BIPOC (Black, Indigenous and People of Color) communities and older adults, is a painful reminder of the health disparities in our country.”
While Asian and Native Hawaiian/Pacific Islander participants turned out to be equitably represented, Dr. Pergam continued, “This collaborative work highlights a problem that’s plagued the scientific community for too long—inadequate representation in clinical trials. The diversity seen in the COVID1-9 vaccine trials demonstrate we can do this, but we need to assure future studies focus not just on rapid enrollment but also on inclusion.”
Ongoing Problems with Data Inclusion
While the National Institutes of Health and the U.S. Food and Drug Administration continue to emphasize the importance of diversity and inclusion of minority groups, for example, in studies this research team continued to find problems with capturing and underreporting.
One of the senior authors of this study out of Harvard Medical School in the Department of Physical Medicine and Rehabilitation, Dr. Julie Silver, said, “Going forward, we need to ensure all vaccine studies report demographic information. Dr. Silver acknowledged that they made some significant strides in collecting data from diverse underrepresented populations but emphasized that “racial and ethnic minorities as well as older individuals are frequently not being equitably represented.”
‘Vaccine Hesitancy’: a Real Problem
The authors point out that this lack of engagement and participant can lead to a real problem known as “vaccine resistance and a lack of understanding about safety,” reports Michele Andrasik, senior staff scientist at Fred Hutch and study co-author who also leads engagement efforts for the NIH’s COVID-19 Prevention Network.
Recently, the National Academies of Sciences, Engineering and Medicine set up a committee to improve the representation of women and underrepresented minorities in clinical trials and research, involving study author Dr. Carlos de Rio, professor of medicine at Emory University School of Medicine.
Fred Hutch—an Active Research Center in the Pandemic
Fred Hutch researchers are playing a leading role in an international scientific response to the pandemic — tracking the virus’s global spread, developing diagnostic tests and monoclonal antibodies that neutralize the virus, designing and evaluating COVID-19 vaccines in early and late-phase clinical trials, and working to better understand how the human immune system can provide durable protection and prevent future outbreaks. Even as the scientific community rapidly works towards vaccines and treatments, we can all do our part to keep our communities safe right now by wearing face coverings and maintaining physical distancing. Check out Fred Hutch’s Coronavirus Overview.