Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020

Steinberg, Jecca R.; Magnani, Christopher J.; Turner, Brandon E.; Weeks, Brannon T.; Young, Ann; Lu, Connie Fei; Zhang, Naixin; Richardson, Michael; Fitzgerald, Alison Conway; Mekonnen, Zesemayat K.; Redman, Tene; Adetunji, Modupe O; Martin, Shanique; Anderson, Jill N.; Chan, Katelyn S.; Milad, Magdy P.

doi:10.1097/aog.0000000000004735

Cited by 9 publications

(6 citation statements)

References 41 publications

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“…Our previous analyses demonstrated most clinical trials that disseminate findings either report results to ClinicalTrials.gov or publish in a peer-reviewed journal . Thus, we included data from both sources in separate parallel analyses.…”

Section: Methodsmentioning

confidence: 99%

“…We included trials from before and after the implementation of the Final Rule for ClinicalTrials.gov after our previous sensitivity analysis accounting for the Final Rule demonstrated similar results with respect to race and ethnicity reporting and representation in the years proceeding and after the implementation of the Final Rule (eAppendix 2 in the Supplement). The methods to select and categorize OB-GYN trials by subspecialty were described previously . All trials were linked to PubMed’s MEDLINE bibliographic database with unique trial identifying numbers from ClinicalTrials.gov to extract publications published before October 2021 .…”

Section: Methodsmentioning

confidence: 99%

“…Data sources included the ClinicalTrials.gov registry, 19 PubMed, 20 and Google Scholar 21 publication databases in addition to the 2010 Census. 22 The 2010 Census was selected because 2010 falls near the midpoint of the study. Additionally, 2010 provides a more conservative estimate of the outcomes compared with the 2020 census given the documented increases in diversity between 2010 and 2020.…”

Section: Data Sourcesmentioning

confidence: 99%

“…Additionally, 2010 provides a more conservative estimate of the outcomes compared with the 2020 census given the documented increases in diversity between 2010 and 2020. 22 The study included only publicly available data and was exempt from oversight by the Stanford Institutional Review Board. The study follows Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.…”

Section: Data Sourcesmentioning

confidence: 99%

“…Race and ethnicity data were then recategorized (eg, Mexican American recategorized as Latinx) to align with US Census and Department of Health and Human Services guidelines. 22…”

Section: Key Pointsmentioning

confidence: 99%

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

Steinberg

Turner²,

DiTosto

et al. 2023

JAMA Surg

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Data Sourcesmentioning

confidence: 99%

Section: Data Sourcesmentioning

confidence: 99%

“…Race and ethnicity data were then recategorized (eg, Mexican American recategorized as Latinx) to align with US Census and Department of Health and Human Services guidelines. 22…”

Section: Key Pointsmentioning

confidence: 99%

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