Representation of Sex, Race and Ethnicity in MASH Randomised Controlled Trials: A Systematic Review and Meta-Analysis

Background and Aims

Randomised controlled trials (RCTs) have historically underrepresented female, racial and ethnic minorities across various fields. This systematic review and meta-analysis aims to examine the global distribution, reporting and participation of diverse groups based on sex, race and ethnicity in trials focused on metabolic dysfunction-associated steatohepatitis (MASH).

Methods

PubMed and Cochrane Library databases were systematically searched for MASH RCTs (through December 13, 2024) that included any pharmacotherapy as an intervention arm. RCTs were qualitatively reviewed to assess their global distribution and reporting of populations. A meta-analysis of proportions was performed using a generalised linear mixed model.

Results

One hudred and nine studies were identified, reporting data from 112 RCTs and 19 516 MASH participants. Of the 49 countries that conducted trials, 34 were high-income countries (69.4%). Sex, race and ethnicity were reported in 111 (99.1%), 69 (61.6%) and 56 (50.0%) of the 112 RCTs, respectively, with reporting improving in recent years. We found no reporting of sexual and gender minorities. The pooled proportions of female, White, Asian, Black and Hispanic/Latino groups were 54.23% (95% confidence interval [CI]: 51.31–57.12), 87.63% (95% CI: 85.37–89.58), 4.95% (95% CI: 3.42–7.10), 2.27% (95% CI: 1.89–2.71) and 31.42% (95% CI: 26.61–36.66), respectively. Meta-regressions showed a trend toward more female, White and Hispanic/Latino participants in RCTs over time.

Conclusions

Although female and Hispanic/Latino representation has increased over time, racial minorities are underrepresented in MASH trials. These data provide an overview of participant representation in MASH trials and call for collaborative efforts among researchers, sponsors, regulators and other relevant stakeholders to improve diversity in these trials.