This story is part of a series on Diversity in Clinical Trials, which will explore the impacts of drug development using data that does not reflect the diverse U.S. population.
To read more in this series, please visit the "Diversity in Clinical Trials" Issue in Focus page here.
Barriers to entry in clinical trials start right from the beginning: a database that only reports in English despite the fact that 66 million U.S. residents speak a language other than English at home, according to U.S. Census Bureau figures.
Clinicaltrials.gov, the government's official database for all clinical trials, is not searchable by language, nor can it identify trials that recruit in languages other than English.
"[This] is the primary way people search for clinical trials that are suitable for them," Us Against Alzheimer's chief of staff Jason Resendez said.
Even if a Non-English speaking person were able to navigate the website and get enrolled in a medical study, the patient would likely not have a translator, therefore running into issues of consent — which is crucial to the integrity of a clinical trial.
Thousands of cancer trials are active in the U.S., with Texas — one of the most diverse states in the country — boasting the second-highest number, as of Oct. 15. Texas Life Science Foundation project director Deborah Vollmer Dahlke called it a "majority minority state," citing strong Hispanic and Vietnamese communities. The second and third most spoken languages are Spanish and Vietnamese, respectively.
And yet, Dahlke said many trials do not provide the essential informed consent documents in any language besides English, an issue not exclusive to cancer.
"Hospitals have a requirement … in terms of treatment, to provide a translator," Dahlke said, "[but] not for trials."
Some organizations, such as the Metastatic Breast Cancer Alliance, are engineering a tool to develop clinical trial portals that may be easier to navigate than Clinicaltrials.gov and support languages besides English.
Worta McCaskill-Stevens, the National Cancer Institute's chief of community oncology and prevention trials research, said all of the NCI's informed consent documents are translated into Spanish. Moreover, the institute now has funding to make translations available for data collection tools at certain sites.
The National Institute on Aging also translates available materials into languages other than English and includes depictions of diverse communities in its educational medical literature.
Even if technological developments fill some of the gaps in document translation, Dahlke said a clinician with an understanding of different cultures may be required to facilitate communication during a clinical trial.
Eli Lilly and Co.'s senior adviser of clinical innovation, Joseph Kim, said multilingual, multicultural understanding is critical when discussing consent in clinical research — beyond just translating documents.
"Consent is a whole understanding and autonomy of a person to know what they're doing, and to understand the risks and benefits of doing that," Kim said. "The patient that speaks Korean or Spanish or Russian needs to be able to have the right relationship with the right clinician so that they can always maintain their consent, or at least express their consent in the informed way."
The clock drawing test is a simple measure of a patient's cognitive status.
While some clinical research uses empirical measures such as blood draws or scans to gauge the effectiveness of a therapy, other studies may require a language or cultural component, such as in Alzheimer's, which occasionally uses a measure called the clock drawing test.
The clock test asks an Alzheimer's patient to illustrate a specific time by drawing an analog clock face with the corresponding hour and minute hands.
A digital version of the test also uses algorithms generated by the Massachusetts Institute of Technology to evaluate the length of the patients' pauses and how well they performed.
Kim said the test may not be applicable to certain cultures that "don't use that kind of clock, or maybe someday in the future you pluck someone from an indigenous tribe in Brazil, are they going to understand a clock face test?"
"If you can't apply it faithfully … that research isn't for that person," Kim said. "As sad as it is, certain patients aren't fit for research for a variety of reasons. Sometimes language and culture happen to be one of them."
According to Kim, accommodating every single person across every single language in a clinical trial "wouldn't be fair" to patients because simply translating the language does not necessarily account for the cultural and personal understanding necessary for ongoing consent.
But Resendez, who is also executive director of Latinos Against Alzheimer's, said a lack of multilingual ability is evident "across the board," another result of a homogeneous healthcare professional workforce that excludes minorities.
"We need all hands on deck, so language really shouldn't be a barrier," Resendez said. "That means investing in training and identifying a bilingual staff, having a pipeline of folks from medical schools, nursing schools — people who are bilingual having a pathway to go into Alzheimer's research programs."