Consent document translation expense hinders inclusive clinical trial enrolment.

Autor: Velez MA; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA., Glenn BA; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.; Department of Health Policy and Management, University of California, Los Angeles, Los Angeles, CA, USA.; UCLA Center for Cancer Prevention and Control Research, University of California, Los Angeles, Los Angeles, CA, USA.; UCLA Kaiser Permanente Center for Health Equity, University of Califonia, Los Angeles, Los Angeles, CA, USA., Garcia-Jimenez M; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.; Division of Hematology/Oncology, UCLA-Olive View Medical Center, Los Angeles, CA, USA., Cummings AL; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA., Lisberg A; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA.; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA., Nañez A; Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, CA, USA., Radwan Y; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA., Lind-Lebuffe JP; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA., Brodrick PM; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA., Li DY; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA., Fernandez-Turizo MJ; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA., Gower A; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA., Lindenbaum M; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA., Hegde M; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA., Brook J; Department of Medicine Statistics Core, University of California, Los Angeles, Los Angeles, CA, USA., Grogan T; Department of Medicine Statistics Core, University of California, Los Angeles, Los Angeles, CA, USA., Elashoff D; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.; Department of Medicine Statistics Core, University of California, Los Angeles, Los Angeles, CA, USA., Teitell MA; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.; Department of Pathology and Laboratory Medicine, University of California, Los Angeles, Los Angeles, CA, USA., Garon EB; Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, Los Angeles, CA, USA. egaron@mednet.ucla.edu.; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA. egaron@mednet.ucla.edu.
Jazyk: angličtina
Zdroj: Nature [Nature] 2023 Aug; Vol. 620 (7975), pp. 855-862. Date of Electronic Publication: 2023 Aug 02.
DOI: 10.1038/s41586-023-06382-0
Abstrakt: Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA 1-3 . As these patients often have limited English proficiency 4-7 , 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.
(© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)
Databáze: MEDLINE
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