JAMA Network Open published an analysis of 230 U.S.-based vaccine trials conducted from July 2011 through June 2020.1 Most analyzed trials did not report demographics for the nearly 220,000 total participants, but those that did had underrepresented racial and ethnic minorities. Notably, white people accounted for roughly 78% of all participants, but Black/African Americans accounted only for 11%, Hispanics/Latinos for 12%, and American Indians/Alaska Natives for just 0.4%.The COVID-19 pandemic showed why the lack of representation in vaccine clinical research is a pressing issue. According to Clinical Infectious Diseases, the Centers for Disease Control and Prevention (CDC) reported that African Americans made up 21.8% and Latinx people made up 33.8% of COVID-19 cases in the U.S., even though these groups only constitute 13% and 18% of the country’s total population, respectively.2
The data from both reports indicate we are underprepared and underequipped to protect traditionally underserved swaths of the population from the threat of vaccine-preventable diseases. However, the problem of diversity in vaccine research isn’t just about making sure vaccines are safe and effective for people of all races and ethnicities. Increasing diversity in vaccine clinical trials can also improve vaccination rates among minorities, who often lack trust in vaccine safety or are undereducated about vaccines. Engaging with underrepresented groups earlier in the vaccine life cycle better addresses their common vaccine education and trust issues.
The Complexity of Increasing Diversity in Vaccine Clinical Trials
Unfortunately, at first glance, there is no simple path to more diversity in vaccine research, because it’s not a simple problem. There are multiple complex reasons why minorities are underrepresented in vaccine studies. While every patient is different and therefore has unique reasons for participating or not participating in research, the most common reasons can be broken down into two main challenges: access and trust.
Access is a primary reason why vaccine clinical trials are lacking in diversity. Like other therapeutic areas, vaccine research is commonly performed at large research centers or big hospitals. However, many minorities don’t live near these facilities or have any connection with them from established relationships with physicians, effectively excluding these minorities from hearing about or being comfortable enrolling in vaccine studies. Many sponsors want to enroll more diverse participants, but because they work within their established collection of sites, they simply can’t find or don’t have access to minority or underrepresented groups.
Trust is the other leading reason why vaccine clinical trials are lacking in diversity. Many members of minority groups have a long-standing mistrust of healthcare and clinical research, and for good reason. Clinical research is stained with a well-documented history of racist or otherwise unethical practices, giving minorities no reason to trust that participating in research won’t do them or their community harm. Even if sponsors were to identify and access underrepresented populations for a trial, they would still have trouble achieving diverse enrollment because such populations might feel their participation is unsafe or unwanted.
A Multifaceted Approach for a Complex Issue
In the face of such complexity, how do we increase diversity in vaccine research?
Elligo Health Research® uses a pioneering, multifaceted approach that navigates the intricacies of participation barriers to naturally increase diversity in vaccine research. As the ultimate healthcare-enabling research organization, we focus on supporting access to and trust in clinical trials.
To increase access to vaccine research participation, Elligo uses electronic health record (EHR) data to match known, diverse patients to clinical trials. We offer a direct connection to more than 150 million known patients through HIPAA-compliant identified EHR data, so sponsors can identify diverse patients quickly and easily, accelerating the enrollment process and removing the access challenges that come with traditional enrollment methods. Historically, Black/African American and Hispanic/Latino research participation wavers between 2% and 16%3, whereas our PatientSelect patient identification and engagement model results in 26% Black/African American and Hispanic/Latino research participation.
To increase trust in the research industry and process, Elligo engages with healthcare practices that are open to offering research as care, as well as established research sites in traditionally underrepresented communities, creating a site network that not only has unprecedented access to diverse populations but is also built upon well-established, trusting relationships with patients, leading to higher rates of research participation. We use unique research agreements and supportive platforms at the site selection stage of a study to characterize patient populations at research sites and further ensure the availability of qualified sites in diverse areas. Elligo is also constantly working toward gaining and retaining patient trust by supporting established physician-patient relationships and engaging with advocacy and support groups to educate patients about the research process.
The Simple Path?
One could argue there is a simple path to more diversity in vaccine research, after all: partnering with Elligo.
By working with Elligo, you gain access to known, diverse patients and research sites in traditionally underserved communities, allowing you to enroll a more inclusive participant group and ultimately deliver a vaccine that protects everyone, regardless of race, ethnicity, age, or gender.
Contact us today to get started.
References:
- Flores, L.E., et al. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Network Open. Published 2021 February 19.
- Tai, D.B.G., et al. The Disproportionate Impact of COVID-19 on Racial and Ethnic Minorities in the United States. Clinical Infectious Diseases, 72(4), Pages 703-706. Published 2021 February.
- Dearment, A. As precision medicine grows, so does the importance of clinical trial diversity. MedCity News. Published 2019 July 7.