A UCLA study has found that cancer research centers conducting clinical trials could enroll more patients from underrepresented groups by relieving investigators of the costs of translating consent documents into languages other than English.
The study was published in the journal Nature.
“We identified a readily addressable weakness in the clinical trial process, and we believe that overcoming this barrier, as we have begun to do, will ensure better representation of trial participants from traditionally underrepresented racial and ethnic groups, enabling researchers to provide more comprehensive, ‘generalizable’ study results,” said Dr. Edward Garon, the study’s senior author and a medical oncologist at the UCLA Jonsson Comprehensive Cancer Center.
Consent documents are required to be in a language understandable to the patient, and studies sponsored by pharmaceutical companies — which represent about 70% of all randomized cancer clinical trials — typically have budgets that cover the costs of translating documents into languages appropriate for participants.
But in studies that are not sponsored by drug companies or device makers, investigators often operate on a fixed, per-patient budget provided by a grant, often from philanthropic organizations or governmental groups. As a result, unexpected costs like fees for translating consent documents, reduce the funds available for other potentially important aspects of the research.
The UCLA researchers theorized that such additional costs could discourage investigators from recruiting patients for whom consent document translation would be required, which could in turn contribute to the disproportionately low rates of participants from traditionally underrepresented groups in clinical trials.