1. Participant Diversity in United States Randomized Controlled Trials of Antibacterials for Staphylococcus aureus Infections, 2000–2021.
- Author
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Kwon, Jiye, Pelletiers, William, Peña, Jessica Galloway, Duin, David van, Ledbetter, Leila, Baum, Keri, Ruffin, Felicia, Knisely, Jane M, Bizzell, Erica, Fowler, Vance G, Chambers, Henry F, and Pettigrew, Melinda M
- Subjects
ANTIBIOTICS ,PATIENT selection ,ALASKA Natives ,STAPHYLOCOCCAL diseases ,DIVERSITY & inclusion policies ,AFRICAN Americans ,RESEARCH funding ,HUMAN research subjects ,SEX distribution ,DEMOGRAPHIC characteristics ,RANDOMIZED controlled trials ,AGE distribution ,DESCRIPTIVE statistics ,METHICILLIN-resistant staphylococcus aureus ,RACE ,BLACK people ,ODDS ratio ,CONFIDENCE intervals ,NATIVE Americans ,DISEASE incidence - Abstract
Background Equitable representation of members from historically marginalized groups is important in clinical trials, which inform standards of care. The goal of this study was to characterize the demographics and proportional subgroup reporting and representation of participants enrolled in randomized controlled trials (RCTs) of antibacterials used to treat Staphylococcus aureus infections. Methods We examined randomized controlled registrational and strategy trials published from 2000 to 2021 to determine the sex, race, and ethnicity of participants. Participant to incidence ratios (PIRs) were calculated by dividing the percentage of study participants in each demographic group by the percentage of the disease population in each group. Underrepresentation was defined as a PIR < 0.8. Results Of the 87 included studies, 82 (94.2%) reported participant sex, 69 (79.3%) reported participant race, and 20 (23.0%) included ethnicity data. Only 17 (19.5%) studies enrolled American Indian/Alaskan Native participants. Median PIRs indicated that Asian and Black participants were underrepresented in RCTs compared with the incidence of methicillin-resistant S. aureus infections in these subgroups. Underrepresentation of Black participants was associated with a larger study size, international sites, industry sponsorship, and phase 2/3 trials compared with phase 4 trials (P <.05 for each). Black participants had more than 4 times the odds of being underrepresented in phase 2/3 trials compared with phase 4 trials (odds ratio, 4.57; 95% confidence interval: 1.14–18.3). Conclusions Standardized reporting methods for race and ethnicity and efforts to increase recruitment of marginalized groups would help ensure equity, rigor, and generalizability in RCTs of antibacterial agents and reduce health inequities. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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