Volume 180, January 2024, Pages 86-90Author links open overlay panel, , , , AbstractObjectives

A lack of diversity amongst participants in cancer clinical trials has raised scrutiny over the past decade. Patients with limited English proficiency (LEP) are further excluded. One modifiable reason for low LEP participation is a lack of non-English consent forms.

Methods

We queried the clinical trials registry database at an academic hospital serving a predominantly Spanish-speaking patient population. Clinical trials related to gynecology oncology were evaluated for the availability of fully translated Spanish consent forms, the racial and ethnic identification of enrolled patients, and the number of signed Spanish consents. Enrolment data was compared before and after 2019, when institutional financial support for document translation was withdrawn.

Results

Sixteen gynecologic oncology clinical trials were opened between 2014 and 2022, with 10 trials enrolling 128 patients. Eight trials opened prior to 2019, all with fully translated consent forms. Seven of these trials enrolled 99 participants, 70% of whom identified as Hispanic and 60% who signed a Spanish consent. Eight trials opened after 2019 and one had a fully translated consent form. Three of the trials enrolled 29 participants, with 10% of subjects identifying as Hispanic and none signing a Spanish consent form.

Conclusions

There was a decrease in fully translated clinical trial consent forms for gynecologic oncology studies following the loss of subsidized translation services in our single institution with a predominantly LEP population. This correlated with a decrease in enrollment of Hispanic subjects. To increase enrollment of diverse participants, including those with LEP, simple actions such as fully translating consent forms would help maintain equity in research conduct and improve clinical outcomes through trial involvement.

Section snippetsLimited English proficiency and diversity in clinical trials

Clinical trials provide cutting-edge advancements in oncologic care which can lead to improvements in survival and quality-of-life. They are recommended as the best management option for patients with advanced disease within the National Comprehensive Cancer Network practice guidelines [1]. However, clinical trial participation levels have historically remained low and homogenous, with significant under-enrollment of minority and low-socioeconomic status patients [2,3], despite having

Methods

The Los Angeles General Medical Center (LAGMC) is affiliated with the University of Southern California (USC) Norris Comprehensive Cancer Center, a National Cancer Institute (NCI)-designed cancer center. It serves a large Hispanic patient population, with approximately 70% of the patients in the gynecologic oncology clinic reporting Spanish as their preferred language. We explored the availability of Spanish-language informed consents by querying the clinical trials registry database for

Results

There were 380 active clinical trials at LAGMC/USC in August 2022, and 11 were related to gynecologic oncology. Six additional trials were identified over the past decade that had closed, but one did not have consent form data. We thus evaluated 16 gynecologic oncology clinical trials at LAGMC/USC for our analysis from 2014 until August 2022. Four trials were industry-related, three were investigator-initiated, and the rest were NCI- or NRG Oncology-sponsored. Ten studies had enrolled 128

Discussion

Data from our single institution showed that after withdrawal of translation services there was a decrease in the number of fully translated Spanish trial consent forms and a decrease in the percentage of enrolled Hispanic subjects. Given the significant expense of formal translation, this one institutional act may significantly impact the number of Hispanic and Spanish-speaking participants in clinical trials, particularly when funding is limited. Notably, the only study with translated

Funding

Ensign Endowment for Gynecologic Cancer Research (Koji Matsuo). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Prior presentation

Presented as a poster at the 2023 Society for Gynecologic Oncology's Annual Meeting on Women's Cancer; Mar 24-28, 2023; Tampa, Florida.

CRediT authorship contribution statement

X. Mona Guo: Conceptualization, Formal analysis, Methodology, Writing – original draft, Writing – review & editing. Monica K. Neuman: Writing – review & editing. Andrew Vallejo: Writing – review & editing. Koji Matsuo: Conceptualization, Supervision, Writing – review & editing. Lynda D. Roman: Conceptualization, Supervision, Writing – review & editing.

Declaration of Competing Interest

Dr. Lynda Roman reports consulting for Cardiff Oncology, Nutcracker Therapeutics and AXDEV as well as participation in the Steering Committee for the Global Coalition of Adaptive Research. The remaining authors do not report any relevant conflicts of interest.

Acknowledgements

The authors would like to acknowledge Marissa Aldana and Charanya Ram Kumar of the USC Norris Cancer Center research staff for their assistance in obtaining consent information.

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