Racial and Ethnic Representation in Us-based Clinical Trials Among Very Preterm Infants: A Systematic Review

Yvette Chop, Nationwide Children’s Hospital, United States; Angelo Naples, The Abigail Wexner Research Institute at Nationwide Children's Hospital, United States; Brian K. Rivera, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, United States; Lauren Capaci, Nationwide Children's Hospital, United States; Sara Conroy, Center for Perinatal Research, The Abigail Wexner Research Institute, Nationwide Children’s Hospital, United States; Carl Backes, Nationwide Children's Hospital, United States; Valencia Walker, The Ohio State University College of Medicine/Nationwide Children's Hospital, Columbus, OH, United States; Stephanie K. Napolitano, Nationwide Children's Hospital, Dublin, OH, United States

Background: The National Institute of Health mandates inclusion and reporting of racial/ethnic minority groups in clinical trial research. While trends in the underrepresentation of these groups in contemporary clinical studies are well described in adult and pediatric populations, this issue has received less attention among studies of infants born very preterm ( < 32 weeks gestation). Imbalance in representation may question the data's generalizability and usefulness to improve health equity.

Objectives: To assess racial and ethnic representation in US-based clinical trials among very preterm infants.

Design/Methods: PubMed and Scopus were searched 01/01/2010-12/31/2019 with no language restrictions. Our search strategy yielded 3,332 studies. We included clinical trials with a mean (or median) gestational age at birth < 32 weeks of gestation and performed in the US. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram for systematic reviews was used for independent extraction by multiple investigators. The primary outcomes were the prevalence of demographic subgroups in each trial according to the trial start year, study region, and sponsor (e.g. government/NIH versus non-government [industry, private foundation]). To compare changes in reporting over time, cohort was divided into 2 epochs (early: 2010-2014; late: 2015-2019). Participation rates were expressed as percentages.

Results: A total of 192 clinical trials were included in the study, totaling 23,044 preterm infants (Table 1). Nearly 40% of studies did not report any racial demographics. Of the 118 trials reporting patient racial demographics, the total population was 32.4% Black, 49.6% White, and 6.8% other races/ethnicities, including Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native (Table 2). Of the studies reporting race and ethnicity, only two-thirds reported Hispanic / Latinx population (66.1%). We found no differences in the proportion of studies that did not report of racial/ethnic distribution based on epoch (early: 38.0%, late: 39.0%; p>0.9) or study sponsor (government: 33.8% versus non-government: 41.5%; p=0.29) (Table 3).

Conclusion: This analysis highlighted both significant heterogeneity and the alarming paucity of racial demographic data documented in US clinical trials of very premature infants, without improvement despite study time or funding source. There is a need to have specific plans, follow-up, and accountability on equitable and inclusive enrollment in clinical trials.