What is your preferred language? Evaluating equal access to oncology clinical studies for non-English-speaking participants.
Authors: Idossa Dame , Velazquez Manana Ana I. , Horiguchi Miki , Suero-Abreu Giselle Alexandra , Franco Idalid Ivy , Borrero Maria , Patel Shruti Rajesh , Dhawan Natasha , Florez Narjust 
Published: June 2023

6547 Background: Oncology clinical research studies (CRS) are essential for developing new therapies and improving patient outcomes, yet the lack of diversity among research participants remains an issue. The logistical complexity of participating in CRS, lack of funding, limited location of study sites, socioeconomic barriers, and the exclusion of non-English speakers (NES) likely contribute to this lack of diversity. In this study, we sought to evaluate what proportion of oncology CRS exclude NES. Methods: We searched ClinicalTrials.gov on December 28, 2022, to identify registered oncology CRS in the most prevalent cancer types: breast, lung, colorectal, and prostate cancers. Only US based studies were included. We reviewed the inclusion and exclusion criteria of each study and identified those that excluded NES. Trials with available informed consent forms (ICFs) were examined to evaluate length, available languages, and readability. Descriptive analysis and chi-squared tests were used to explore associations between study characteristics and the exclusion of NES. Results: We identified 12,393 CRS, of which 2527 were excluded due to duplicates listed under more than one cancer type. Of 9866 evaluable studies, 1195 (12%) explicitly excluded NES individuals from participating. Of these, 161 (13%) allowed Spanish-speaking participants. Breast cancer trials had the highest proportion of CRS which excluded NES (17%), followed by trials in colorectal (13%), prostate (9%), and lung (7%) cancer. When analyzed by funding sources, studies funded by academic institutions had the highest proportion of CRS that excluded NES individuals (24%) compared to 15% of NIH funded, 19% of other government-funded, and 2% of industry-funded studies (p<0.001). Compared to interventional studies, observational research studies were more likely to exclude NES (11% vs 20%; p<0.001). Notably, most CRS did not have ICFs available online. Of the 242 (2%) studies that had ICFs available for review, only 3 (1%) had ICFs available in another language – all of which were in Spanish. Furthermore, many ICFs were lengthy, with a median of 11 pages (range 1-54), and complex, with a median readability of 12th grade Flesch Kincaid level (range 6-26). Conclusions: Many oncology CRS, especially those funded by academic institutions, exclude NES, impacting 1 in 10 individuals in the US. This exclusion is not always explicit, making it likely that our findings underestimate the issue. Requiring English proficiency for research study participation will continue to contribute to the underrepresentation of historically excluded populations and NES patients with cancer from clinical trials and other research studies. Eliminating exclusionary criteria based on language and providing adaptive resources for NES participants is crucial for ensuring that oncology research is inclusive and grounded in equity.