Use of gender-neutral language in clinical trial protocols in select cancers.

Garima Gupta University of Kentucky, Lexington, KY info_outline Garima Gupta, Zin Myint, Donglin Yan, Reema Anil Patel

Authors Garima Gupta University of Kentucky, Lexington, KY info_outline Garima Gupta, Zin Myint, Donglin Yan, Reema Anil Patel Organizations University of Kentucky, Lexington, KY Abstract Disclosures Research Funding No funding received None. Background: Around 21% of Generation Z Americans self-identify as lesbian, gay, bisexual, transgender (LGBT), nearly double the proportion of millennials. Despite Affordable Care Act Section 1557 in 2020, transgender individuals continue to have poor access to quality cancer care, including clinical trials. The National Institutes of Health (NIH) recognizes that using gender-neutral language in healthcare is one of many ways to improve sexual and gender minorities (SGM) related health disparities. This study examines use of gender-neutral language in clinical trial protocols in select cancers. Methods: Data was collected from clinicaltrials.gov, a commonly used resource for patients and providers. Phase III clinical trials with all recruitment statuses in the US from 2017 to 2022 were included. Cancer types were limited to those with highest risk of using gender-biased language: breast, ovarian, endometrial, fallopian tube, cervical, prostate, testicular, and penile. For each trial, frequency of use of following terms was recorded by searching under study details section: male, female, she, her, he, his, him, man/men, woman/women, breastfeeding/nursing/lactating/pregnant mother or female or woman. Mean frequency was compared between 2017-19 and 2020-22 using Wilcoxon signed-rank test. Funder type, eligible sex, gender-based eligibility and gender eligibility description were also collected. Data were compared between 2017-19 (pre-1557) and 2020-22 (post-1557) using Fisher exact test. Results: 243 studies were included in the analysis; 130 were pre- and 113 were post-1557. 103/130 (80%) studies between 2017-19 and 78/113 (70%) between 2020-22 included at least one gender-biased term or “male/female” outside of eligible sex description ( p = 0.05), depicting a trend towards improvement; stronger improvement was noted in non-NIH funded studies versus NIH-funded studies. Mean frequency of gender-biased terms was higher in 2017-19 compared to 2020-22 (2.25 vs 1.88, p = 0.02). 27/130 studies (21%) between 2017-19 and 21/113 (19%) of studies between 2020-22 required gender-based eligibility ( p = 0.40). Amongst these, 100% of studies between 2017-19 and 95% of studies between 2020-22 either provided no description or used this clause incorrectly, commenting on sex assigned at birth and not gender identity. This indicates lack of awareness regarding difference between sex assigned at birth and gender identity. While it is evident to investigators during registration on clinicaltrials.gov that eligible sex refers to biological sex, it is not to anyone reviewing the trial for enrollment, resulting in implicit bias. Conclusions: Our study highlights the dire need to address SGM-related health disparities and brings attention towards paucity of gender-neutral language in clinical trial protocols. This step is critical in providing more inclusive care and capturing the rising population of LGBT individuals.