Abstract
Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1,2,3. As these patients often have limited English proficiency4,5,6,7, 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 12,000 consent events at a large cancer centre 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 the translation costs) than for industry-sponsored studies (for which the translation costs are 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. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.
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Data availability
All consent-event data associated with this study and data contained in Extended Data tables are freely available at https://doi.org/10.5281/zenodo.7992491.
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Acknowledgements
We thank J. Allen and R. Flores Stella for their assistance. E.B.G. was funded by NIH-NCI R01 CA276917, the Cancer Center Support Grant P30 CA016042, and NIH-NCATS UL1TR001881, CLIN-10784. A.L.C. was funded by a Specialty Training and Advanced Research (STAR) Award. A.L. was funded by NIH-NCI K08 CA245249-01A1 and a LUNGevity 2019 Career Development Award. E.B.G. is also funded by CLIN-10784. M.A.T. was funded by P30 CA016042- Cancer Center Support Grant, UCLA Jonsson Comprehensive Cancer Center. D.E. was funded by the National Center for Advancing Translational Science (NCATS) of the National Institutes of Health under the UCLA Clinical and Translational Science Institute grant number UL1TR001881. Figure 1 was created using BioRender.com. This work was funded by E.B.G.’s UCLA Jonsson Comprehensive Cancer Center Seed Grant.
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M.A.V., B.A.G. and E.B.G. contributed substantially to the conception and design of the work. M.A.V., A.N., Y.R., J.P.L.-L., P.M.B., D.Y.L., M.J.F.-T., M.L., M.H., J.B., T.G., D.E. and E.B.G. contributed to data acquisition, analysis and interpretation. M.A.V. and E.B.G. drafted the paper. B.A.G., A.L.C., M.G.-J., A.G., M.A.T., A.L. and E.B.G. contributed substantially to paper revision.
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E.B.G. has been a consultant and/or advisor for Abbvie; ABL-Bio; AstraZeneca, Boehringer-Ingelheim; Bristol-Myers Squibb; Dracen Pharmaceuticals; EMD Serono; Eisai; Eli Lilly; Gilead; GlaxoSmithKline; Ipsen; Merck; Natera; Novartis; Personalis; Regeneron; Sanofi; Shionogi; and Xilio. E.B.G. has received grant or research support from ABL-Bio; AstraZeneca; Bristol-Myers Squibb; Dynavax Technologies; Eli Lilly; EMD Serono; Genentech; Iovance Biotherapeutics; Merck; Mirati Therapeutics; Neon; and Novartis. A.L. has received commercial research grants from Daiichi Sankyo, Calithera Biosciences, AstraZeneca, Dracen Pharmaceuticals, WindMIL, eFFECTOR Therapeutics. A.E.L. has served as a consultant or on the advisory board for, AstraZeneca, Bristol-Myers Squibb, Leica Biosystems, Jazz Pharmaceuticals, Novocure, Pfizer, MorphoSys, Eli Lilly, Oncocyte, Novartis, Regeneron, Janssen oncology, Sanofi group of companies. M.A.V., B.A.G., M.G.-J., A.N., Y.R., J.P.L.-L., P.M.B., D.Y.L., M.J.F.-T., A.G., M.L., M.H., J.B. and T.G. declare no competing interests.
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Extended data figures and tables
Extended Data Fig. 1 Comparison of the proportion of consent events based on primary language and English proficiency in interventional industry versus non-industry sponsored studies.
a. Blue indicates the proportion of consent events for patients with English as their primary language. Yellow indicates the proportion of consent events for patients with a primary language other than English in industry sponsored studies (top bar) versus non-industry sponsored studies (bottom bar) (8.2% versus 4.0%, p < 0.001). b. Blue indicates the proportion of consent events for patients with English as their primary language. Red indicates the proportion of consent events for patients with limited English proficiency in industry sponsored studies (top bar) versus non-industry sponsored studies (bottom bar) (5.6% versus 2.5%, p < 0.001). Logistic regression models with Generalized Estimating Equations clustered by patient unique identifier were used to test comparisons above, P values reported are two-tailed.
Extended Data Fig. 2 Comparison of the percentage of patients signing consent documents per study between industry and non-industry sponsored studies.
The X axis depicts the percentage of patients signing consent documents for each study who had a primary language other than English in industry (a) and non-industry sponsored studies (b). Each study is represented by a row in the Y axis. The rows are taller for non-industry sponsored studies compared to industry sponsored studies as there are fewer of them. Green denotes the percentage of patients who signed consent in their primary language, pink represents the percentage of patients signing consent documents in a language different than their primary language and red represents the percentage of patients with limited English proficiency signing consent document in a language different than primary.
Supplementary information
Supplementary Methods
This file includes further information about the study population, definitions of groups and subgroups, definitions of primary language and limited English proficiency, correct versus incorrect language in which patients signed consent documents, and variables included in statistical analyses as well as handling of missing data.
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Velez, M.A., Glenn, B.A., Garcia-Jimenez, M. et al. Consent document translation expense hinders inclusive clinical trial enrolment. Nature 620, 855–862 (2023). https://doi.org/10.1038/s41586-023-06382-0
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DOI: https://doi.org/10.1038/s41586-023-06382-0
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