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Background: Clinical trials are essential for developing safe and effective medical treatments across broad, generalizable populations. Individuals from historically underrepresented racial and ethnic groups participate at disproportionately low rates, constraining the generalizability of research outcomes and limiting clinical trial access for already marginalized communities. Recent reports suggest that greater than 20% of American residents identified as speaking a language other than English in their home, with rates above 70% among those individuals who identify as Hispanic or Asian. Access to translated consent documentation becomes increasingly important for the inclusion of patients with limited English proficiency (LEP) in on-going cancer clinical trials to ensure adequate representation of racially/ethnically diverse patient populations and advancing healthcare equity.

Objective: This study evaluates the impact of translated consent documentation availability on the time to consent for cancer clinical trial from charted documentation of diagnosis or progression on prior therapy in patients receiving cancer care.

Methods: The primary study outcome was the time from disease diagnosis or progression on prior therapy to signed clinical trial consent measured in days. Data for this study were derived from consent-event records for clinical studies generated during the two most recent competitive renewal periods of the Jonsson Comprehensive Cancer Center (JCCC) with the date of disease diagnosis or progression was determined through manual electronic medical record (EHR) chart review and data extraction. Patients were categorized by language status as noted on EHR systems (English vs LEP/non-English). Continuous variables were summarized as median and interquartile range (IQR). Between-group comparisons were performed using the Wilcoxon rank sum test. A p-value less than 0.05 was considered statistically significant. All analyses were performed using R.

Results: A total of 4,452 patients were included in this analysis with 4,129 (92.7%) identified as primarily English-speaking and 323 (7.3%) as LEPP/non-English-speaking. English-speaking patients had significantly shorter time to consent of 17 days (IQR 7-37) compared to 23 days (IQR 1.5 -40.5) among LEP patients (p=0.003).

Among LEP patients, three subgroups were identified based on the language availability of consent documentation. Group 1 consisted of patients who signed consents in their preferred language when a translated consent was already available (n = 32), with a median time to consent of 18 days. Group 2 consisted of patients who signed consents in English despite being LEP (n = 192), with a median time to consent of 19 days. Group 3 consisted of patients for whom no consent was readily available in their preferred language (n = 96), with a median time to consent of 27 days. Group 3 had a significantly longer time to consent compared to both Group 1 and Group 2 combined (p = 0.003).

Conclusions: These findings suggest that language barriers are a potential cause for delayed access to cancer clinical trials in non-English speaking patients. Availability of consent material in a patient’s preferred language represents a potentially modifiable barrier to clinical trial enrollment for marginalized groups. Expanding access to translated consent documentation may serve as a meaningful step toward improving health equity in clinical trials.