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Diversity and transparency in gynecologic oncology clinical trials.

Publication ,  Conference
Montes de Oca, MK; Howell, EP; Spinosa, D; Knochenhauer, H; Peipert, BJ; Severson, E; Ramkissoon, S; Akinyemiju, TF; Previs, RA
Published in: Cancer Causes Control
February 2023

PURPOSE: Clinical trials advance the standard of care for patients. Patients enrolled in trials should represent the population who would benefit from the intervention in clinical practice. The aim of this study was to assess whether clinical trials enrolling patients with gynecologic cancers report racial and ethnic participant composition and to examine the level of diversity in clinical trials. METHODS: Using ClinicalTrials.gov, we identified clinical trials enrolling patients with ovarian, uterine/endometrial, cervical, vaginal, and vulvar cancers from 1988 to 2019. Race and ethnicity data were extracted from participant demographics. Descriptive statistics on race, ethnicity, cancer type, location, study status, and sponsor type were calculated. Among trials which reported race and/or ethnicity, sub-analyses were performed on composition of race and ethnicity by funding source, location, and completed study status. RESULTS: A total of 1,882 trials met inclusion criteria; only 179 trials (9.5%) reported race information. Of these, the racial distribution of enrollees was 66.9% White, 8.6% Asian, 8.5% Black/African American, 0.4% Indian/Alaskan Native, 0.1% Native Hawaiian/Pacific Islander, 1.0% more than one race, and 14.5% unknown. Only 100 (5.3%) trials reported ethnicity. Except for trials enrolling patients with cervical cancer which enrolled 65.2% White and 62.1% Non-Hispanic/Latino/a patients, enrollees in trials for other gynecologic cancers were over 80% White and 88% Non-Hispanic/Latino/a. Industry funded trials enrolled higher proportions of White (68.4%) participants than non-industry funded trials (57.5%). Domestic trials report race (11.5%) and ethnicity (7.6%) at higher rates than international trials (6.9% and 2.3%, respectively). Reporting of race (1.7% vs. 13.9%) and ethnicity (1.7% vs. 11.1%) has increased over time for patients enrolled in 2000 vs. 2018. CONCLUSION: Less than 10% of trials enrolling patients with gynecologic malignancies report racial/ethnic participant composition on ClinicalTrials.gov. Accurate reporting of participant race/ethnicity is imperative to ensuring minority representation in clinical trials.

Duke Scholars

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Published In

Cancer Causes Control

DOI

EISSN

1573-7225

Publication Date

February 2023

Volume

34

Issue

2

Start / End Page

133 / 140

Location

Netherlands

Related Subject Headings

  • United States
  • Minority Groups
  • Humans
  • Genital Neoplasms, Female
  • Female
  • Ethnicity
  • Epidemiology
  • Clinical Trials as Topic
  • 4202 Epidemiology
  • 3211 Oncology and carcinogenesis
 

Citation

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Montes de Oca, M. K., Howell, E. P., Spinosa, D., Knochenhauer, H., Peipert, B. J., Severson, E., … Previs, R. A. (2023). Diversity and transparency in gynecologic oncology clinical trials. In Cancer Causes Control (Vol. 34, pp. 133–140). Netherlands. https://doi.org/10.1007/s10552-022-01646-y
Montes de Oca, Mary Katherine, Elizabeth P. Howell, Daniel Spinosa, Hope Knochenhauer, Benjamin J. Peipert, Eric Severson, Shakti Ramkissoon, Tomi F. Akinyemiju, and Rebecca A. Previs. “Diversity and transparency in gynecologic oncology clinical trials.” In Cancer Causes Control, 34:133–40, 2023. https://doi.org/10.1007/s10552-022-01646-y.
Montes de Oca MK, Howell EP, Spinosa D, Knochenhauer H, Peipert BJ, Severson E, et al. Diversity and transparency in gynecologic oncology clinical trials. In: Cancer Causes Control. 2023. p. 133–40.
Montes de Oca, Mary Katherine, et al. “Diversity and transparency in gynecologic oncology clinical trials.Cancer Causes Control, vol. 34, no. 2, 2023, pp. 133–40. Pubmed, doi:10.1007/s10552-022-01646-y.
Montes de Oca MK, Howell EP, Spinosa D, Knochenhauer H, Peipert BJ, Severson E, Ramkissoon S, Akinyemiju TF, Previs RA. Diversity and transparency in gynecologic oncology clinical trials. Cancer Causes Control. 2023. p. 133–140.
Journal cover image

Published In

Cancer Causes Control

DOI

EISSN

1573-7225

Publication Date

February 2023

Volume

34

Issue

2

Start / End Page

133 / 140

Location

Netherlands

Related Subject Headings

  • United States
  • Minority Groups
  • Humans
  • Genital Neoplasms, Female
  • Female
  • Ethnicity
  • Epidemiology
  • Clinical Trials as Topic
  • 4202 Epidemiology
  • 3211 Oncology and carcinogenesis