Assessing the financial implications of translating oncology clinical trial informed consent forms in the U.S.

53 Background: Language barriers affect millions in the US, where nearly 8% of individuals (~ 26 million) have limited English proficiency, making it harder to access, understand, and engage with healthcare services. As clinical trials enroll increasingly diverse participants, ensuring the accessibility and clarity of consent forms is critical. Understanding translation costs can improve budgeting and prevent enrollment delays for non-English-speaking participants. This study evaluates the costs of translating consent forms into three of the most widely spoken non-English languages in the U.S. Methods: In February 2025, we queried ClinicalTrials.gov to identify publicly available consent forms for phase 3 interventional trials in lung, breast, GI, & GU cancers from 2013–2024. In total, 18 consent forms were identified. The U.S. News top 20 U.S. cancer centers were contacted to identify commonly used certified translation companies. We obtained quotes from 8 IRB-certified agencies via online portal for Spanish, Simplified Chinese, and Tagalog translations. Results: The 18 informed consent forms were on average 14 pages long (range: 3-29 pages). Across the 8 translation companies, translating documents into Spanish (average price per document [$pD]: 1088.58) was cheaper than Chinese (average $pD: $1253.94, p < 0.001) and Tagalog (average $pD: $1399.07, p < 0.001). Costs varied significantly by company (p < 0.001). Quality assurance measures, including dual translation and proofreading, were included in 87.5% of quotes. The average turnaround time for translating one consent into 3 different languages was 4 business days (range: 2-8 business days). Conclusions: The cost of translating informed consent forms for oncology clinical trials varies significantly by language and translation company, with Spanish translations being the least expensive and Tagalog the most costly. While translation costs represent a small fraction of overall trial expenses, variability in pricing and turnaround times underscores the need for structured budgeting and standardized translation processes. Translations of informed consents should ideally be completed prior to trial initiation to avoid the delayed recruitment or exclusion of non-English speaking patients. Our results are valuable for researchers & sponsors involved in oncology clinical trials, helping them make informed decisions in budgeting regarding language translation services. Company ID Average $pD, Spanish Average $pD, Chinese Average $pD, Tagalog Spanish $pW Chinese $pW Tagalog $pW 1 840.11 1,054.07 1,054.07 0.16 0.20 0.20 2 1,109.63 1,553.49 1,775.41 0.22 0.28 0.32 3 945.00 1,081.50 1,422.33 0.10 0.17 0.12 4 1,880.56 1,880.56 2,131.94 0.30 0.30 0.34 5 875.35 875.35 875.35 0.15 0.15 0.15 6 1,029.98 1,367.56 1,472.93 0.27 0.36 0.39 7 929.72 978.65 1,125.45 0.14 0.15 0.17 8 1,042.39 1,184.50 1,279.22 0.33 0.37 0.41