Patients with limited English proficiency are likely to be systematically excluded from clinical trials, which may contribute to the underrepresentation of certain racial and ethnic groups in cancer research. This is given that people with limited English proficiency often form part of historically underrepresented racial and ethnic groups. Individuals from historically underrepresented racial and ethnic groups are less likely to join cancer clinical trials than individuals from higher-represented racial and ethnic groups. These individuals also are more likely to have limited English proficiency.
This led researchers at UCLA Jonsson Comprehensive Cancer Center to ask questions. Do costs associated with consent document translation dissuade investigators running non-industry studies from offering patients with limited English proficiency, who require translated consent documents, the opportunity to participate in those studies? They conducted a study to answer this question (Nature 2023; https://doi.org/10.1038/s41586-023-06382-0). 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, noted the answers to these questions are a small part of what leads to disparities in cancer clinical trials and cancer care. "I think we need to address it like we approach all cancer research... in a very targeted way," she said. "The same goes for researching disparities. It's a huge problem, but there's not going to be one huge solution. I think there's going to be small solutions and, as they add up, they're going to make a big difference over time."
1 Explain your analysis of whether any translation costs affect minority participation?
"We decided on a study period that was already set by the cancer center (to avoid a potential source of investigator bias)-the last competing renewal period for our cancer center, which spans from 2013 to 2018. Then we looked at data for all the consent events-when a patient signed a consent form. It doesn't matter if the patient ended up enrolling in the study or screening out of the study; if they signed a consent form, they were included in the study that we ran. We ended up with a total of about 12,000 consent events we were able to include in the study.
"Then we looked at the difference in the proportion of consent events in patients with limited English proficiency in studies that were primarily sponsored and funded by an industry partner versus those that were not. When a study is funded and sponsored by industry, the funds are much less restricted and it's easier for investigators to translate however many consent forms they want because, ultimately, those costs will be completely covered by the industry partner. Whereas in studies with other funding streams, consent form translation costs may or may not be covered. If they're not, investigators often have to find ways of covering those costs via their institution or other grants. That's why we looked at the proportion between those types of studies and the difference in the proportion of consent events, which was significantly different between patients with limited English proficiency in industry versus non-industry studies.
"When patients did sign consent forms in studies not sponsored by industry, we looked if the investigators translated the consent forms. We found that actually they often did not. It was very often that, when patients signed a consent form that was not sponsored by industries, they signed the consent in English. So even if the patient clearly required a translated consent document (because we knew they had limited English proficiency) they were not presented with one."
2 What were the key research findings?
Patients with limited English proficiencies who likely required a translated consent form were less likely to participate in non-industry sponsored studies compared to industry-sponsored studies. When they did participate in a non-industry-sponsored study, they often signed consent form documents in a language different from their primary language. This is why we think that the cost of translation of consent is a barrier to enrollment. Ultimately, the proportion of patients with limited English proficiency is small, but we think it is a barrier to the participation of these patients in clinical studies. While this doesn't address all of the barriers in terms of inclusion of historically underrepresented groups in clinical trials, we do think this addresses one of the barriers to the inclusion."
3 What solutions might help this problem?
"One of the things this data brought about was our cancer center looking at ways it can support investigators, especially [for] non-industry studies in which they can access extra funds for translation of consent form documents. I think one of the important solutions at the institutional level is that cancer centers could support investigators running these types of studies when it comes to helping them access extra funds they otherwise wouldn't have to translate consent forms.
"Another important aspect is that, when there is an industry partner, really make sure that partner is willing and able to cover the cost of translating consent forms. Lastly, when people apply for an NIH or other grant, the cost of translating consent forms should be budgeted.
"Our next research steps are looking at the true cost of enrolling patients with limited English proficiency into studies considering all translation costs. Translation cost is not an easy number for cancer clinical trial investigators to estimate upfront. The cost varies depending on how extensive the consent form is. Less common languages are usually more expensive to translate. And whenever there's a change to the protocol of the study that you have to disclose to patients, you will have to retranslate the consent form. So, it can be really hard for the investigators to know at the beginning of the study how many times they will have to amend the consent form."