Year: 2023
Type: article
Study design: Observational Study
Abstract: 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.
Source: Nature
Authors: Maria A. Velez, Beth A. Glenn, Maria Garcia-Jimenez, Amy L. Cummings, Aaron Lisberg, Andrea Nañez, Yazeed Radwan, Jackson P. Lind-Lebuffe, Paige M. Brodrick, Debory Y. Li, Maria J. Fernandez-Turizo, Arjan Gower, Maggie Lindenbaum, Manavi Hegde, Jenny Brook, Tristan Grogan, David Elashoff, Michael A. Teitell, Edward B. Garon
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Gilead Sciences, Regeneron Pharmaceuticals, Novocure, Mirati Therapeutics, Calithera Biosciences, Natera, Eisai, Shionogi, MorphoSys, Ipsen, National Institutes of Health, Genentech, EMD Serono, National Cancer Institute, National Center for Advancing Translational Sciences, Jonsson Comprehensive Cancer Center, Clinical and Translational Science Institute, University of California, Los Angeles, Daiichi Sankyo Europe
Awards: Intratumoral Administration of CCL21-gene Modified Dendritic Cell With Intravenous Pembrolizumab for Advanced NSCLC, HLA B44 motif neoepitopes in NSCLC: Evaluating their effects on the TME and adding them to established markers in a model to predict durable benefit from PD- 1 inhibition with and without chemotherapy, Cancer Center Support Grant, UCLA Clinical and Translational Science Institute
OpenAlex ID: W4385498098