Consent document translation expense hinders inclusive clinical trial enrolment

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA . As these patients often have limited English proficiency , we hypothesized that one barrier to their inclusion is the cost to investigators of tra...

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Bibliographic Details
Published in:Nature (London) 2023-08, Vol.620 (7975), p.855-862
Main Authors: Velez, Maria A, Glenn, Beth A, Garcia-Jimenez, Maria, Cummings, Amy L, Lisberg, Aaron, Nañez, Andrea, Radwan, Yazeed, Lind-Lebuffe, Jackson P, Brodrick, Paige M, Li, Debory Y, Fernandez-Turizo, Maria J, Gower, Arjan, Lindenbaum, Maggie, Hegde, Manavi, Brook, Jenny, Grogan, Tristan, Elashoff, David, Teitell, Michael A, Garon, Edward B
Format: Article
Language:English
Subjects:
Cancer
Clinical trials
Clinical Trials as Topic - economics
Communication Barriers
Consent
Consent Forms - economics
Corporate sponsorship
Costs
Documents
Drug Industry - economics
Hispanic people
Humans
Hypotheses
Language
Minority & ethnic groups
Participation
Patients
Pediatrics
Research Personnel - economics
Translating
Translation
Translations
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Summary:Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA . As these patients often have limited English proficiency , 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.
ISSN:0028-0836
1476-4687
DOI:10.1038/s41586-023-06382-0