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

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 suboptimally defined. This systematic review evaluated demographic reporting and participant representation in 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 and 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 OR [aOR], 14.2; P < .01). Inclusion of US participants was the sole factor significantly associated with reporting race (aOR, 13.0; P < .01) and ethnicity (aOR, 12.9; P < .01). Among 70 US-enrolling studies, Asian participants were overrepresented relative to a national ILD registry, whereas Black and Hispanic/Latino participants were underrepresented. No studies reported using non-English recruitment materials; 1 study reported patient navigation or coaching.

Our results show that 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.

PROSPERO; No.: 1057947; URL: https://www.crd.york.ac.uk/prospero/.