Addressing Social Determinants Of Health To Improve Clinical Trial Diversity
By Deborah Borfitz
April 9, 2021 | Health equality does not assure health equity, where the focus is on fixing root problems so access to tools and resources is possible across populations, according to Laurie Myers, global health literacy director at Merck, during a keynote presentation on the relevance of social determinants of health (SDOH) to clinical trials at the recent Summit for Clinical Ops Executives (SCOPE).
SDOH describe the conditions where individuals live, learn, work, and play that affect their health risks and conditions, Myers says. One of the components is economic stability, such as financial resources and whether people have enough food and a place to call home. Others include education level and native language, conditions in the community and neighborhood where individuals live, their ability to work from home, and healthcare access and quality.
Health disparities are linked to disadvantages based on a host of factors such as race and ethnicity, religion, social class, age, disabilities, and geographic location, she continues. Potential barriers to clinical trial diversity include mistrust, fear, logistical constraints, and lack of awareness and information about studies.
SDOH can be an added obstacle—but can also be an equalizer if action is taken on them, adds Myers. An important consideration is whether clinical trials are being offered in neighborhoods where people routinely go for healthcare. Trust, or distrust, in clinical research is also influenced by the views of family, friends, and social media connections.
The pandemic has only highlighted preexisting disparities, given that racial and ethnic minorities are both more likely to get and die from COVID-19, Myers says. “It is essential to create systematic support to foster participation of underrepresented populations,” including community awareness and education efforts that reflect diverse populations.
Among the non-health factors impacting how people experience the pandemic are residential crowding, the need to go to work, and job losses leading to food insecurity and health-related conditions, says Myers. Sponsors have a “moral and ethical obligation” to address these factors to help increase clinical trial diversity.
Tackling Health Literacy
Solutions for improving trial diversity include community engagement through the delivery of meaningful communications and leveraging real-world data to improve site selection and investigator diversity, Myers continues. Much can also be done to improve the “cultural sensitivity” of investigators who are not diverse, she adds, and the teach-back method is a great way to confirm understanding.
As she later shared in a panel session, investigators are “not insulted by this. They appreciate it.” Merck has trained investigators in health literacy and cultural competency and says the assessment around unconscious bias has been “incredibly well received.”
She also notes that the MRCT Center of Brigham and Women’ Hospital and Harvard has a health literacy site with helpful resources.
Other helpful steps are to improve digital literacy and access to computers and internet connections, as well as increase screening for and collection of SDOH data, she says.
Community partnerships are essential when it comes to addressing SDOH in the context of clinical trials, adds Myers. Targeted populations need to be viewed as people and have their needs (e.g., transportation and babysitting) addressed comprehensively.
Her recommendations are to work with “trusted voices,” understand systemic racism and distrust, follow health literacy practices, and provide needed technology, high-speed internet, and flexible ways to participate in trials. One of the objectives of the ongoing Healthy People 2020 initiative of the U.S. Department of Health and Human Services is to improve the ability of people to understand and use health information, which “anyone can struggle with,” she notes.
Health literacy means the ability to ask questions and discern quality information as well as being able to navigate the web to acquire knowledge, says Myers. The ability to understand and use numbers is essential for anyone with diabetes, for example.
The research enterprise is riddled with jargon that is hindering literacy, she says, starting with the “clinical trial” term. “A ‘trial’ is what happens in front of a jury when someone is charged with a crime.” Another potential conundrum for a lay audience is use of the word “drug,” since cocaine or heroin might immediately jump to mind.
In the same vein, Myers adds, would-be clinical trial participants need to understand the time commitment going in if sponsors hope to improve retention and curtail non-adherence and, ultimately, the generalizability of study results.