Systematic Review of Participant Sex, Race and Ethnicity Reporting in Interstitial Lung Disease Clinical Trials.

Abstract

Improving the generalizability of interstitial lung disease (ILD) research requires inclusion of diverse populations in clinical trials. Despite ongoing efforts to improve racial and ethnic minority participation, reporting and representation of sex, race, and ethnicity in ILD studies remain sub-optimally defined. This systematic review evaluated demographic reporting and participant representation in recent ILD clinical trials. What is the current state of sex, race, and ethnicity reporting and representation in ILD clinical trials, and what strategies are being implemented to enhance diversity and generalizability? We systematically searched PubMed, EMBASE, and Web of Science for ILD clinical trials published in English between 2013-2023. Eligible studies were original research and enrolled adults with sample sizes ≥10. Standardized data abstraction captured study characteristics, recruitment strategies, and participant demographics. Descriptive statistics and multivariable regression assessed associations between study characteristics and both demographic reporting and enrollment diversity. Among 241 included studies, sex was reported in 94%, whereas race and ethnicity were reported in only 27% and 8%, respectively. Race and ethnicity reporting showed nonsignificant upward trends; sex was more likely to be reported after 2018 (adjusted odds ratio [aOR] 14.2, p<0.01). Inclusion of US participants was the sole factor significantly associated with reporting race (aOR 13.0, p<0.01) and ethnicity (aOR 12.9, p<0.01). Among 70 US-enrolling studies, Asian participants were overrepresented relative to a national ILD registry, while Black and Hispanic/Latino participants were underrepresented. No studies reported using non-English recruitment materials; one reported patient navigation or coaching. This systematic review delineates the current state of participant demographics in ILD clinical trials, establishing a critical benchmark for future recruitment efforts. The frequent omission of race and ethnicity data despite consistent sex data underscores a need for standardized demographic reporting and intentional strategies to enhance the diversity and generalizability of ILD trials.