Patients from historically underrepresented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the United States 1-3 . As these patients often have limited English pro ciency [4][5][6][7] , we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than twelve-thousand consent events at a large Cancer Center and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays translation costs) than for industry sponsored studies (for which this cost is covered by the sponsor). Here, we show that the proportion of consent events for patients with limited English pro ciency in studies not sponsored by industry was approximately half of that seen in industry sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry sponsored studies. Our results suggest that the cost of consent document translation in trials not sponsored by industry is a potentially modi able barrier to the inclusion of patients with limited English pro ciency.

6533 Background: Racial/ethnic minority patients (pts) are underrepresented in cancer clinical trials. Challenges specific to LEPPs include the need for translated CDs, which can cause research delays and add cost. While most enrollment barriers are similar between industry sponsored studies (ISS) and NISS, costs of CD translation are typically covered by the sponsor in ISS. NISS often have limited, or no funds allocated for CD translation. Although it is required that LEPPs sign translated CDs, we hypothesized that investigators on NISS would find ways to avoid incurring the cost of CD translation. Methods: All pts who consented to studies at the UCLA Jonsson Comprehensive Cancer Center from 2013-2018 were included. Electronic health record data was reviewed. Adult LEPPs had a primary language other than English and their chart either flagged them as needing an interpreter or the pt used an interpreter in their care 6 months before or after the consent date. For pediatric patients, regardless of the pt’s primary language, LEPPs had a guardian who needed an interpreter within 6 months of the consent date. CD language was documented when available by chart review, but when not, we evaluated all IRB-approved CDs for the corresponding study and assumed that the pt signed appropriately translated CDs if available at the time of consent or within the following month. Chi square tests were used to compare the proportion of LEPPs who consented to NISS vs ISS and the proportion of LEPPs who consented with CDs not in their primary language. All analyses were performed using JMP, Version 16. SAS Institute Inc., Cary, NC, 1989–2021. Results: Although we do not have access to data on to whom consents were offered, of the 12202 consenting events during the study period, the proportion of consenting events for LEPPs was 2.7% in NISS vs 5.4% for ISS (p < 0.01). This difference did not appear to be driven by study type, as results were similar when only consenting events for interventional studies (n = 9886) were considered, with LEPPs representing 2.4% in NISS vs 5.5% in ISS (p < 0.01). Among LEPPs, 67.2% of participants who consented to NISS consented with CDs in a language other than their primary language vs 32.2% in ISS (p < 0.01). LEPPs who consented with language appropriate CDs represented 0.9% of those consenting to NISS vs 3.7% for ISS (p < 0.01). Conclusions: LEPPs consented less frequently to NISS compared to ISS, and when they did consent to NISS, the CDs were usually not translated into the pt’s primary language. We posit that the cost of translating CD discourages investigators from consenting LEPPs to NISS. Approaches that reduce or eliminate translation costs should increase the availability of translated CDs, potentially increasing enrollment of LEPPs to NISS while ensuring that they are fully informed about the purpose, procedures, and risks involved in these trials.

6553 Background: Patients (pts) from historically underrepresented groups often have limited English proficiency (LEP). One challenge specific to obtaining consent from these pts to participate in clinical trials is the need for translated CDs. CD translation leads to enrollment delays and increases costs to study sponsors. We hypothesized that NISS, for which the principal investigator pays translation costs, would consent proportionately fewer pts with a primary language other than English and pts with LEP compared to industry sponsored studies (ISS). Methods: Pts’ primary language and English proficiency were assessed for all 12,082 consent events with appropriate available data at the Jonsson Comprehensive Cancer Center from 2013 to 2018. Pts with LEP were pts (or parent/guardian for pediatric pts) who had a primary language other than English, and the electronic health record indicated that the pt required a translator within 6 months of the consent date. CD language was documented per chart review when available, and when not, languages of available IRB-approved CDs were evaluated. The proportion of consent events for pts with a primary language other than English and with LEP were compared between NISS and ISS using generalized estimating equations, and the odds of signing CDs in the pts primary language were evaluated by multivariable analyses. Discrepant CD language data was evaluated by McNemar’s test. All analyses were performed using SAS 9 (SAS Institute, Cary, NC, USA). Results: Pts with a primary language other than English represented 8.1% of consent events in ISS vs 4.4% in NISS (p<0.001) and 5.5% vs 2.8% (p<0.001) for pts with LEP. Pts with a primary language other than English represented 4.5% vs 1.2% of consent events utilizing CDs in the pts’ primary language in ISS vs NISS (p<0.001) and 3.7% vs 0.9% (p<0.001) for pts with LEP. On multivariable analyses, the odds for pts with a primary language other than English of signing CDs to a NISS was 0.74 (CI, 0.63-0.94, p=0.005), and of signing CDs in their primary language was 0.38 (CI, 0.27-0.52, p<0.001) compared to pts whose primary language was English. The odds for pts with LEP of signing CD to a NISS was 0.74 (CI, 0.58-0.95, p=0.02), and signing CDs in their primary language was 0.35 (CI, 0.25-0.50, p<0.001) compared to pts whose primary language was English. Of 52 pts who signed CDs for both ≥1 NISS and ≥1 ISS, 18 signed in discrepant languages, with 16 of those 18 signing translated CDs for the ISS but not the NISS (p=0.002). Conclusions: Although the role of cost as an effect driver cannot be proven in a retrospective analysis, consistent with our hypothesis, the proportion of consent events utilizing appropriately translated CDs for pts with a primary language other than English and pts LEP was lower in NISS vs ISS, driven by lower odds of signing CDs and lower frequency of signing translated CDs. Approaches that reduce translation costs for investigators should be investigated.

Patients from historically underrepresented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the United States 1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than twelve-thousand consent events at a large Cancer Center and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays translation costs) than for industry sponsored studies (for which this cost is covered by the sponsor). Here, we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient’s primary language in studies without industry sponsorship was approximately half of that seen in industry sponsored studies. Our results suggest that the cost of consent document translation in trials not sponsored by industry is a potentially modifiable barrier to the inclusion of patients with limited English proficiency.