Cancer research centers conducting clinical trials could potentially enroll more patients from underrepresented racial and ethnic groups by placing a greater emphasis on relieving investigators of the costs of translating consent documents into languages other than English, according to a study published by Velez et al in 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 senior study author Edward B. Garon, MD, a medical oncologist and Director of the Signal Transduction and Therapeutics Program Area at the UCLA Jonsson Comprehensive Cancer Center.
Study Background
Consent documents presented to potential clinical trial participants are required to be in a language understandable to the patient, and studies sponsored by pharmaceutical companies—about 70% of all randomized cancer clinical trials—typically have budgets that cover the costs of translating documents into languages appropriate for participants. 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, an unexpected cost, such as the cost of consent document translation, often reduces the funds available for other potentially important aspects of the research.
The UCLA research team theorized that these additional costs could discourage investigators from recruiting patients for whom consent document translation would be required, contributing to the disproportionately low rates of participants from traditionally underrepresented groups in clinical trials.
Study Methods
Researchers analyzed “consent events”—situations in which consent documents were signed—and compared those for industry-sponsored studies vs studies not sponsored by industry. Each “event” did not necessarily represent a single patient, because some participants signed consent documents for multiple trials.
Dr. Garon and colleagues evaluated potential differences in the two types of trials based on participant primary language and English proficiency, basing their findings on more than 12,000 consent events that included 9,213 participants in trials at the UCLA Jonsson Comprehensive Cancer Center between January 2013 and December 2018.
KEY POINTS
- 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.
- Among patients signing consent documents, 63.4% were non-Hispanic White, of whom only 1.6% had a primary language other than English. In contrast, 18.3% of participants from other racial and ethnic groups had a primary language other than English, the most common being Spanish, with Chinese as the second most common.
Results
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. When patients from this group signed 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.
Among patients signing consent documents, 63.4% were non-Hispanic White, of whom only 1.6% had a primary language other than English. In contrast, 18.3% of participants from other racial and ethnic groups had a primary language other than English, the most common being Spanish, with Chinese as the second most common.
“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,” explained Maria Velez, MD, a fellow in hematology and oncology at the David Geffen School of Medicine at UCLA and the lead author of the study.
“Removing this hurdle and increasing representation is important, because efficacy, toxicity, and clinical outcomes of a studied treatment may be different in different populations. Also, many studies focus on screening, prevention, survivorship, and quality-of-life issues—topics that can best be understood through the inclusion of a diverse patient population,” added Beth Glenn, PhD, Co-Director for Community Outreach and Engagement at the UCLA Jonsson Comprehensive Cancer Center and co-author of the study.
Disclosure: For full disclosures of the study authors, visit nature.com.
