Participation of Black and Hispanic women in clinical trial evidence for NCCN preferred systemic therapies in advanced ovarian cancer

Abstract

<h3>Objectives:</h3> Minority participation in clinical trials is important for expanding opportunities in access to cancer therapies and may aid in understanding racial disparities in oncology care. Prior studies have identified underrepresentation in gynecologic oncology phase I recruitment and large group trials in the United States, but minority participation specific to trials that drive current treatment recommendations remains unclear. We sought to evaluate minority participation as described in publications of curated, high quality clinical evidence for ovarian cancer therapies as identified by the National Comprehensive Cancer Network (NCCN). <h3>Methods:</h3> NCCN Clinical Practice Guidelines for Ovarian Cancer, Version 1.2020, was accessed in order to identify evidence provided for ‘preferred' primary and recurrent systemic therapies and dosing regimens in advanced epithelial ovarian cancer using explicitly listed citations. Race and ethnicity data of trial enrollment provided in publications listed as references was manually abstracted. <h3>Results:</h3> We identified 26 prospective trials including 13,887 participants, published across 5 journals: <i>New England Journal of Medicine, Lancet, Lancet Oncology, Gynecologic Oncology,</i> and <i>Journal of the National Cancer Institute.</i> All were phase II or III trials and 96% of trials were published in or more recently than 2003. Of these trials, race or ethnicity was reported in only 9 publications (35%). Of these 9 publications, there was marked language variation between trials in reporting race and ethnicity. There were 7 trials that included a description of participants as Black or African American. Of the 4,701 women who participated in these trials, 206 were Black or African American, representing approximately 4% of trial participants. There were 4 trials that included a description of participants as Hispanic. Of the 3,436 women who participated in these trials, 152 were Hispanic, representing approximately 4% of trial participants. <h3>Conclusions:</h3> Of the clinical trial evidence for preferred systemic therapies identified in the NCCN clinical practice guidelines for advanced ovarian cancer, minority participation was reported in less than half of publications and description of race and ethnicity varied between trials. Of trials that reported minority participation, Black and hispanic women represented <5% of trial participants, respectively.