A Call to Action: A Systematic Review Examining the Failure to Include Females and Members of Minoritized Racial/Ethnic Groups in Clinical Trials of Pharmacological Treatments for Alcohol Use Disorder

Abstract

Alcohol use disorder (AUD) presents a significant public health concern given the high prevalence estimates and numerous deleterious-associated consequences. The FDA currently has approved 3 pharmacological treatments for alcohol use disorder: acamprosate, naltrexone, and disulfiram. Previous research suggests that there may exist differences in the prevalence of and outcomes related to AUD across sex and racial/ethnic groups. Other work indicates that there may be differences in the efficacy of existing pharmacological treatments for AUD across demographic groups. The purpose of the present study was to examine the inclusion of women and members of minoritized racial/ethnic groups in published randomized clinical trials of pharmacological treatments for alcohol use disorder since 1994, in accordance with the NIH Revitalization Act of 1993. PubMed was systematically searched using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The initial search located 842 articles. After exclusion of ineligible articles, 102 remained for analysis. Of those included in the review, only 11.8% reported full sex and racial/ethnic characteristics of their study participants. Of the total sample, 6 articles were specifically examining 1 racial/ethnic group, and 11 were specifically examining 1 sex. Two articles (2.2%) did not report information regarding the sex breakdown of their participants, while 47 (49.0%) did not report any information regarding the racial/ethnic breakdown of their sample. Despite guidelines set forth by NIH, only 5.9% of articles conducted subgroup analyses to examine differences in treatment outcomes by sex or race/ethnicity, and only 16.7% of articles included considerations related to cultural inclusion when discussing study limitations. These results varied by medication type. Results suggest that considerably greater efforts must be put forth by the larger scientific community regarding the inclusion, analysis, and reporting of data focused on women and non-White racial and ethnic groups.

Diversity inclusion in United States opioid pharmacological treatment trials: A systematic review.

“…Furthermore, grant reviewers (especially for NIH funded research) should ensure proposed articles include samples representative of OUD prevalence (and perhaps focus on groups disproportionately affected by related health disparities). It may be that diverse sample is difficult to obtain due to a mistrust by groups historically treated unethically in research (Harris et al, 1996; Pacheco et al, 2013; Schick et al, 2020). Moreover, as Schick et al (2020) suggest, the lack of diverse representation in RCTs may reflect the lack of diverse researchers and individuals holding graduate degrees; therefore, investing resources to support the careers of researchers from marginalized backgrounds is warranted, as it may increase representative research.…”

“…It may be that diverse sample is difficult to obtain due to a mistrust by groups historically treated unethically in research (Harris et al, 1996; Pacheco et al, 2013; Schick et al, 2020). Moreover, as Schick et al (2020) suggest, the lack of diverse representation in RCTs may reflect the lack of diverse researchers and individuals holding graduate degrees; therefore, investing resources to support the careers of researchers from marginalized backgrounds is warranted, as it may increase representative research. While programs such as certain T-32 NRSA Diversity Supplement Awards, the LEADership, Education and Development (LEAD) program, the McNair Scholars program, and others target these aims, there is still a lack of diverse representation in science and higher education, suggesting the need to continue with such efforts.…”

“…Similarly, patients looking to access more information about treatment options they are considering would not be able to tell whether individuals whose identities are similar to their own were represented in clinical trials testing the different types of medications. As suggested by others, to address such problems, researchers should strive to carefully collect demographic information and report findings, and journal reviewers and editors should require that the articles they publish include full descriptive information of the relevant demographics of their samples (Schick et al, 2020).…”

“…Rates of retention in pharmacological opioid treatment have also been found to be lower for patients who were younger, Black, Hispanic/Latinx, or unemployed (Weinstein et al, 2017). Other possible barriers to treatment for marginalized groups may include a lack of trust in research and/or medical professionals, stigma involved in accessing care (Harris et al, 1996; Pacheco et al, 2013; Schick et al, 2020), or limited access and poor quality of care (Stein et al, 2018); however, it is clear that there are disparities in ability to be successfully treated with pharmacological treatment for an OUD among people from certain demographic groups. Moreover, while there is evidence to support these disparities among relatively larger marginalized racial groups (e.g., Black, Asian, and Latinx), there is a lack of research to support or refute the evidence that disparities exist among groups less-well represented in research, such as AI/AN, Native Hawaiian/Other Pacific Islander (NH/OPI), and multiracial groups; this lack of support suggests that more research is necessary.…”

“…Furthermore, participation in such trials provides opportunities for marginalized and underserved groups to receive potentially greater efficacious medical care (Klein et al, 2015). Concerningly, reviews examining pharmacological treatment for other conditions have found that inclusion of individuals from underrepresented groups is lacking (Chen et al, 2014; Schick et al, 2020). Such underrepresentation is of concern, as it is difficult to conclude how effective a given treatment is within a group for which it has not yet been adequately assessed.…”