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

Abstract

Pharmacological treatments for opioid use disorders (OUDs) may have mixed efficacy across diverse groups, i.e., sex/gender, race/ethnicity, and socioeconomic status (SES). The present systematic review aims to examine how diverse groups have been included in U.S. randomized clinical trials examining pharmacological treatments (i.e., methadone, buprenorphine, or naltrexone) for OUDs. PubMed was systematically searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The initial search yielded 567 articles. After exclusion of ineligible articles, 50 remained for the present review. Of the included articles, 14.0% (n = 7) reported both full (i.e., accounting for all participants) sex/gender and race/ethnicity information; only two of those articles also included information about any SES indicators. Moreover, only 22.0% (n = 11) reported full sex/gender information, and 42.0% (n = 21) reported full racial/ethnic information. Furthermore, only 10.0% (n = 5) reported that their lack of subgroup analyses or diverse samples was a limitation to their studies. Particularly underrepresented were American Indian/Alaska Native (AI/AN), Asian, Native Hawaiian/Other Pacific Islander (NH/OPI), and multiracial individuals. These results also varied by medication type; Black individuals were underrepresented in buprenorphine randomized controlled trials (RCTs) but were well represented in RCTs for methadone and/or naltrexone. In conclusion, it is critical that all people receive efficacious pharmacological care for OUDs given the ongoing opioid epidemic. Findings from the present review, however, support that participants from diverse or marginalized backgrounds are underrepresented in treatment trials, despite being at increased risk for disparities related to OUDs. Suggestions for future research are advanced.

Inclusion and reporting of sex, gender, and race/ethnicity in randomized controlled trials of nonpharmacological treatments for alcohol use disorder: A meta‐epidemiologic review

“…However, participants from diverse sex/gender and racial/ethnic backgrounds were neither routinely nor representatively included in these articles; the majority of participants included appeared to be White and males/men. These findings are largely consistent with the results of other reviews focusing on reporting and inclusion in studies focusing on addiction treatment specifically (Nalven et al, 2021;Schick et al, 2020) and in psychological research broadly (Clark et al, 2019;Gatzke-Kopp, 2016).…”

Diversity inclusion in clinical trials investigating esketamine for depression: A systematic review.

“…MDD among Black and Hispanic/Latinx individuals is also highly prevalent, yet Black individuals were represented at one fifth the rate of White or European Americans and Hispanic/Latinx individuals were represented at one seventh the rate of White individuals (Polo et al, 2019). In line with other pharmacological treatment research (Nalven et al, 2021), these results emphasize that individuals from diverse backgrounds are often underrepresented in clinical trials for MDD treatment, although these figures may be highly skewed or inaccurate given that only 55% of all included RCTs reported participant race/ethnicity information from 2005 to 2016 (Polo et al, 2019). This finding represents a significant increase in reporting from prior decades (Polo et al, 2019); however, this figure remains critically low given the importance of demographic factors on MDD presentation and treatment response.…”

Demographic Diversity of Clinical Trials for Therapeutic Drug Products: A Systematic Review of Recently Published Articles, 2017‐2022

“…Of the 5 (23%) additional articles that reported age, 1 reported findings for pediatric populations exclusively, and the remaining 4 reported both pediatric and adult populations. 13,16,[23][24][25] Three articles (14%) focused on adults who were aged older than 40 and 60 years. 7,15,26 Nalven et al 25 found that participants in clinical trials for interventions to treat opioid use disorder did not reflect the population at risk for this particular disorder.…”