Race and Ethnicity Reporting and Representation in Obstetrics and Gynecology Clinical Trials and Publications From 2007-2020

Abstract

ImportanceClinical trials guide evidence-based obstetrics and gynecology (OB-GYN) but often enroll nonrepresentative participants.ObjectiveTo characterize race and ethnicity reporting and representation in US OB-GYN clinical trials and their subsequent publications and to analyze the association of subspecialty and funding with diverse representation.Design and SettingCross-sectional analysis of all OB-GYN studies registered on ClinicalTrials.gov (2007-2020) and publications from PubMed and Google Scholar (2007-2021). Analyses included logistic regression controlling for year, subspecialty, phase, funding, and site number. Data from 332 417 studies were downloaded. Studies with a noninterventional design, with a registration date before October 1, 2007, without relevance to OB-GYN, with no reported results, and with no US-based study site were excluded.ExposuresOB-GYN subspecialty and funder.Main Outcomes and MeasuresReporting of race and ethnicity data and racial and ethnic representation (the proportion of enrollees of American Indian or Alaskan Native, Asian, Black, Latinx, or White identity and odds of representation above US Census estimates by race and ethnicity).ResultsAmong trials with ClinicalTrials.gov results (1287 trials with 591 196 participants) and publications (1147 trials with 821 111 participants), 662 (50.9%) and 856 (74.6%) reported race and ethnicity data, respectively. Among publications, gynecology studies were significantly less likely to report race and ethnicity than obstetrics (adjusted odds ratio [aOR], 0.54; 95% CI, 0.38-0.75). Reproductive endocrinology and infertility trials had the lowest odds of reporting race and ethnicity (aOR, 0.14; 95% CI, 0.07-0.27; reference category, obstetrics). Obstetrics and family planning demonstrated the most diverse clinical trial cohorts. Compared with obstetric trials, gynecologic oncology had the lowest odds of Black representation (ClinicalTrials.gov: aOR, 0.04; 95% CI, 0.02-0.09; publications: aOR, 0.06; 95% CI, 0.03-0.11) and Latinx representation (ClinicalTrials.gov: aOR, 0.05; 95% CI, 0.02-0.14; publications: aOR, 0.23; 95% CI, 0.10-0.48), followed by urogynecology and reproductive endocrinology and infertility. Urogynecology (ClinicalTrials.gov: aOR, 0.15; 95% CI, 0.05-0.39; publications: aOR, 0.24; 95% CI, 0.09-0.58) had the lowest odds of Asian representation.Conclusions and RelevanceRace and ethnicity reporting and representation in OB-GYN trials are suboptimal. Obstetrics and family planning trials demonstrate improved representation is achievable. Nonetheless, all subspecialties should strive for more equitably representative research.

Enrollment of Racial and Ethnic Minoritized Groups in Gynecologic Oncology Clinical Trials: A Review of the Scope of the Problem, Contributing Factors, and Strategies to Improve Inclusion

“…13 A recent 2022 study assessed representation across all US-based obstetrics and gynecology (OB/Gyn) clinical trials registered on ClinicalTrials.gov and resultant publications (591,196 participants, 2007-2020) and found gynecologic oncology performs the worst of all OB/Gyn subspecialties with respect to Latinx and Black participant enrollment (multivariate regression odds ratios, P < 0.05). 14 These trends appear to continue based on participants included in the most recent practice-changing trials. Some, such as SOLO1 and PRIMA, failed to report race and ethnicity data, in part because of varied demographic definitions across countries.…”

Clinical Trial Reporting and Representation—An Opportunity to Advance Health Equity

“…This study by Steinberg et al 3 demonstrates the need for meaningful dialogue to advance equity in the conduct of clinical research and health outcomes. First, the study further emphasizes the critical need for investigators to better ensure recruitment and enrollment of diverse participants for clinical trials to meet the health needs of an increasingly diverse US population.…”

“…Steinberg and colleagues report findings from a cross-sectional analysis of clinical studies registered at ClinicalTrials.gov (2007-2020) and publications from PubMed and Google Scholar (2007-2021). Among 1287 trials registered in ClinicalTrials.gov with results (591 196 participants) and 1147 publications (821 111 participants), 662 (50.9%) and 856 (74.6%), respectively, reported race and ethnicity data.…”

“…Additionally, diverse recruitment and reporting is important for the ability to inform how social needs and determinants may impact the outcomes reported in clinical trials or observational studies. Finally, the review by Steinberg et al emphasizes the need for editorial guidelines that encourage race and ethnicity reporting. While obstetrical and gynecologic studies have shown improvement in enrollment and reporting, particularly among obstetrical and family planning trials, further work is needed to advance race and ethnicity representation and reporting.…”

Error in the Author Affiliations

“…In the Original Investigation “Race and Ethnicity Reporting and Representation in Obstetrics and Gynecology Clinical Trials and Publications From 2007-2020” published online December 21, 2022, there was an error in the author affiliations. The first author, Jecca R. Steinberg, MD, MSc, is affiliated with the Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine in Chicago, Illinois.…”