Synergy Paper: COVID-19 Exacerbated Inclusion Issues in Biomedical Research
As COVID-19 disrupted the way we live, the pandemic also magnified discernible barriers to inclusion of representative populations in biomedical research.
While the exclusion of “special populations” has ensued for decades, a collaborative and diverse team of health professionals further identified and confronted inequity barriers via investigation of a structural competency framework. The research, supported by a Synergy Paper mechanism through the CTSA Center for Leading Innovation and Collaboration (CLIC), was recently published in the Journal of Clinical and Translational Science.
In March 2020, Northwestern University’s Clinical and Translational Sciences (NUCATS) Institute hosted an “Un-Meeting” on Lifespan and Life Course Research. Chaired by corresponding author Susanna McColley, MD, Associate Clinical Director for Child Health at the NUCATS Institute and professor of Pediatrics in Pulmonary and Sleep Medicine, the Un-Meeting was supported by the Clinical and Translational Science Award (CTSA) Program’s Integration Across the Lifespan Enterprise Committee and CLIC. More than 100 individuals from 75 CTSA sites attended.
Discussions of the meeting and the subsequent paper entailed the identification and expansion of inclusion initiatives in studies from special populations across the lifespan and of data collection for studies across the life course. As the COVID-19 pandemic evolved into a prominent health concern, significant mortality discrepancies arose among “special populations;” the paper’s focus was consequently augmented by pandemic disparities.
People of different ancestral backgrounds, women, children, and elderly people have different risk factors and disease courses and metabolize drugs differently. You can’t just extrapolate data from one group to another.”
“The issue of inclusion of “special populations” in research is not new; it’s been a focus of the National Institutes of Health (NIH) for years dating back to the revitalization act of 1993,” says McColley. “People of different ancestral backgrounds, women, children, and elderly people have different risk factors and disease courses and metabolize drugs differently. You can’t just extrapolate data from one group to another.”
The Un-Meeting sparked an extensive literature review from a structural competency perspective; emphasizing socioeconomic variance and deep-rooted institutional fabrics. This approach to interpreting documents on research inclusion materialized inequities concerning the participation and retention of affected groups in clinical interaction. Structural competency facilitates the promotion of problem-solving for affected individuals and groups to reduce barriers, including stigma, and diversify research participation.
McColley highlights unifying themes of exclusion among “special populations,” the first of which details the lack of access to healthcare and external engagement resources.
“People of lower income, overrepresented by people from racial and ethnic minority groups due to structural racism, are often excluded from research because they have no insurance or are insured by Medicaid. They therefore have less access to physicians and healthcare systems that recruit people for research studies. They may also lack resources needed to participate. For example, oftentimes people aren’t reimbursed for expenses such as meals and transportation, or they may make no income on a day that they devote to a research study visit.”
Additionally, research study design flaws that actively inhibit sample diversity were highlighted in the paper.
“Older adults are often excluded because they often have multiple medical conditions, which are often part of a study’s exclusion criteria. This was an issue for many COVID-19 vaccine and therapy studies, while older adults as a group have the highest mortality from the disease. Children are often excluded for ethical reasons; most new treatments are only studied in children after proven to be safe and effective in adults, but it can take years for these ‘extension studies’ to be done.”
To supplement these concerns, “biomedical researchers and healthcare systems have not shown that they are trustworthy to people from racial and ethnic minority groups,” McColley says. “There is great evidence of bias, misdiagnosis, higher mortality, and poor experience in healthcare settings.”
Considerations of solutions are ongoing but generally necessitate embracing structural humility, which describes the awareness of interpersonal privilege and power hierarchies in healthcare that contribute to a reduction of research facility diversification. Personalized and consistent interaction with trusted healthcare providers is suggested to help address and dismantle systemic barriers.
Practical application in resource allocation and study design can further increase research participant opportunities for those with personal and professional hindrances. This includes alternative options promoting decentralized clinical trials, including clinical trials at home or elsewhere, with the progression of digital technologies.
Comprehensively, progress in diversity in study participation is noted to require effective community engagement. This means an authentic commitment of time and resources as well as creative thinking to solidify a mutually beneficial relationship between participants and healthcare professionals.
Just as increasing diversity in biomedical research participation is the goal of the paper, so is the value of collaborating with 21 authors from a range of scientific backgrounds across CTSA hubs from across the United States in the construction of the manuscript.
“We included medical doctors, nurses, and epidemiologists from a range of fields from ob/gyn to pediatrics to geriatrics and gerontology, psychologists, etc. Diversity in geography, age, and personal attributes also contributed greatly. This multidisciplinary team exemplifies the importance of translational research activities that cross traditional biomedical science boundaries.”
Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, Grant Number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Written by Alex Miranda
