Background

Race and ethnicity play a complex role in healthcare and interact with geography, culture and sociopolitical factors to impact patient care and health outcomes. Biopsychosocial models in healthcare and attention to social determinants of health have led to improved outcomes, yet many clinical trials and studies neglect to report on race/ethnicity. This lack of key demographic information may conceal health disparities as well as invalidate social inequities and implications for population health. While there is an equal distribution of rate of new cases of ovarian cancer across all races/ethnicities, we investigated the inclusion of racial data as well as proportions of race and ethnicity of participants in clinical trials for ovarian cancer treatment.

Objective

The primary objective of this study is to evaluate the proportion of ovarian cancer clinical trials that included demographic information regarding race/ethnicity. The secondary objective is to analyze the proportions of each demographic subgroup amongst all clinical trials that reported race/ethnicity in order to characterize trends in representation.

Design/Methods

A search was conducted using the term “ovarian cancer” on ClinicalTrials.gov. Trials that included completed interventional studies with results were reviewed. Four independent reviewers extracted study level data on race/ethnicity demographic information for a random effects analysis. Studies that did not pertain to ovarian cancer were further excluded. Microsoft Excel was used for data collection and analysis.

Results

An initial search using “ovarian cancer” returned 3201 clinical trials. Of these, 320 trials met initial inclusion criteria. After further review, an additional 15 trials were excluded from analysis as these trials were not related to ovarian cancer. Of the 305 studies included, only 36.7% (n=112) included demographic info on race and 29.5% (n=90) included information on Hispanic/Not Hispanic ethnicity. This resulted in 21,135 total participants for race/ethnicity analysis and 9,303 for additional analysis on Hispanic/Not Hispanic. Within these trials, the majority of participants identified as White (83.3%, n=17,596) versus other races, American Indian (0.3%, n=55), Asian (8.3%, n=1746), Native Hawaiian or Other Pacific Islander (0.1%, n=28), Black or African American (3.5%, n=744), more than one race (0.1%, n=17). 3.2% (n=666) participants were unknown/not reported or identified as Other (1.3%, n=283). The majority of participants reported identifying as Not Hispanic or Latino (92.3%, n=8590).

Conclusions

Current clinical trials on ovarian cancer do not consistently report information on race or ethnicity. Of the studies that did report on race and ethnicity, participants were disproportionately White (83.3%) and Not Hispanic or Latino (92.3%). These results highlight the disparities that persist in the enrollment of diverse participants in clinical trials. Conclusions drawn from these clinical trials on outcomes, safety, and efficacy may not be readily applicable and scalable to all subgroups due to the inequity of representation during these trials. Further investigation is warranted regarding possible barriers to entry for clinical trial enrollment and participation; future efforts to increase diversity in clinical trial enrollment should be pursued.