Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Feb 1;158(2):181-190.
doi: 10.1001/jamasurg.2022.6600.

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

Jecca R Steinberg  1 , Brandon E Turner  2 , Julia D DiTosto  1 , Brannon T Weeks  3 , Anna Marie P Young  1 , Connie F Lu  1 , Tierney Wolgemuth  1 , Kai Holder  1 , Nora Laasiri  1 , Natalie Squires  4 , Naixin Zhang  5 , Michael Taylor Richardson  6 , Christopher J Magnani  7 , Jill N Anderson  4 , Dario R Roque  1 , Lynn M Yee  1
Affiliations

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

Jecca R Steinberg et al. JAMA Surg. .

Erratum in

  • Error in the Author Affiliations.
    [No authors listed] [No authors listed] JAMA Surg. 2023 Feb 1;158(2):224. doi: 10.1001/jamasurg.2022.8308. JAMA Surg. 2023. PMID: 36752802 Free PMC article. No abstract available.

Abstract

Importance: Clinical trials guide evidence-based obstetrics and gynecology (OB-GYN) but often enroll nonrepresentative participants.

Objective: To 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 setting: Cross-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.

Exposures: OB-GYN subspecialty and funder.

Main outcomes and measures: Reporting 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).

Results: Among 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 relevance: Race 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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Roque reported grants from Bristol Myers Squibb Foundation Robert A. Winn Diversity in Clinical Trials Award Program and the National Cancer Institute (grant P20 CA233304-01A1) during the conduct of the study and personal fees from GSK, Myriad Genetics, and ImmunoGen outside the submitted work. Dr Yee reported grants from the National Institutes of Health outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Selection
October 1, 2007, was selected based on the passage of the US Food and Drug Administration Amendments Act of 2007, which required most phase 2 to 4 US-based clinical trials to register with ClinicalTrials.gov.
Figure 2.
Figure 2.. Race and Ethnicity Enrollment Reporting in US-Based Obstetrics and Gynecology (OB-GYN) Clinical Trials Registered on ClinicalTrials.gov and in Subsequent Publications
A, Change over time in proportion of trials reporting race and ethnicity enrollment data. On September 27, 2007, section 801 of the US Food and Drug Administration Amendments Act of 2007 mandated reporting of most clinical trials in the US to ClinicalTrials.gov. On September 21, 2016, the Final Rule was published, recommending the reporting of race and ethnicity for most clinical trials on ClinicalTrials.gov. B, The proportion of each racial and ethnic group reported among trials and publications that included any race and ethnicity enrollment data.
Figure 3.
Figure 3.. Race and Ethnicity Representation in Obstetrics and Gynecology Clinical Trials and Publications
The median percent of each racial or ethnic group by subspecialty in ClinicalTrials.gov results and publications is displayed. The triangle shows the 2010 Census percent of the population for the given race or ethnicity.
Figure 4.
Figure 4.. Association of Trial Features With Representation of Racial and Ethnic Groups in Obstetrics and Gynecology Clinical Trials Reported in ClinicalTrials.gov and Publications
Each plot shows the adjusted odds of above census-level representation and the 95% CI for the listed variable. Each graph represents a different race or ethnicity. For subspecialties, the reference category was obstetrics. For funding, the reference category was government/academic funding. Multivariable logistic regression analysis could not be computed for American Indian and Alaskan Native representation due to small sample size. Multivariable analysis adjusted for year, subspecialty, phase, funding, and site number. aOR indicates adjusted odds ratio; NA, not applicable; REI, reproductive endocrinology and infertility.
See this image and copyright information in PMC

Comment in

References

    1. Nijjar SK, D’Amico MI, Wimalaweera NA, Cooper N, Zamora J, Khan KS. Participation in clinical trials improves outcomes in women’s health: a systematic review and meta-analysis. BJOG. 2017;124(6):863-871. doi:10.1111/1471-0528.14528 - DOI - PubMed
    1. Yamasato K, Chern I, Lee MJ. Racial/ethnic representation in United States and Australian obstetric research. Matern Child Health J. 2021;25(5):841-848. doi:10.1007/s10995-020-03099-8 - DOI - PubMed
    1. Bibbins-Domingo K, Helman A, Dzau VJ. The imperative for diversity and inclusion in clinical trials and health research participation. JAMA. 2022;327(23):2283-2284. doi:10.1001/jama.2022.9083 - DOI - PubMed
    1. Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am. Published online April 10, 2022. doi:10.1016/j.lana.2022.100252 - DOI - PMC - PubMed
    1. Chen MS Jr, Lara PN, Dang JHT, Paterniti DA, Kelly K. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials. Cancer. 2014;120(suppl 7):1091-1096. doi:10.1002/cncr.28575 - DOI - PMC - PubMed