When clinical trial sites, sponsors and tech vendors think about diversity and inclusion, we consider a variety of factors: age, race, ethnicity, gender identity, sexual orientation, ability, and more. But we often forget to think about the importance of language access and clinical trial translations, especially for trials originating in the U.S.
A study of U.S. clinical trials showed that there is a gap between protocols that include translations and the number of Americans who need them:
- 2.7% of clinical trial protocols mentioned translations for languages other than English
- 21.5% of Americans speak a language other than English at home
This lack of translations could exclude more than 66 million people from trials–and that’s only when considering U.S. trials.
Removing English or local language proficiency requirements from clinical trials and ensuring translations are easily available will have tremendous benefits for patient recruitment and patient diversity. Keep reading to learn more about why translations are important and how clinical trial teams can use technology to make them widespread and accessible.
Addressing Clinical Trials’ Lack of Diversity
Roughly 19% of U.S. clinical trials require that participants be proficient in English. Although the other 81% don’t require English proficiency, only 2.7% of them explicitly offer translations in their protocols.
This presents a major problem: even when non-English speakers aren’t deliberately excluded from trials, they are often inadvertently excluded. And this exclusion can also impact racial and ethnic diversity.
For example, 13.2% of the U.S. population speaks Spanish at home, but 97% of clinical trials don’t specify whether or not they can offer Spanish translations.
This same concern applies for patients who speak dozens of other languages, from Cantonese to Tagalog, Vietnamese, French, Korean, and Arabic. Even bilingual people can feel more comfortable when translations are available in their preferred language.
If the clinical trial industry doesn’t reach out to patients in their own languages, sites lose thousands of potential patients from diverse backgrounds, and those patients miss out on potentially life-saving treatments.
Making International Trials Possible and Ethical
With the rise of globalization, many clinical trial drugs are tested in one country but receive approval in another:
- 62% of drugs approved by the FDA are tested outside the U.S.
- The 20 largest U.S. sponsors conduct 33% of their trials outside of the U.S.
International trials can have many positive effects. Pfizer used international trials to get the COVID-19 vaccine trials completed more quickly and with a more diverse patient population than trials typically have. Expanding trials to multiple countries also gives more patients access to cutting-edge medical treatments.
That said, international trials come with a risk of exploitation. If the sponsor creates documents in a language patients aren’t fluent in, it could create confusion over what a trial entails, leading to inaccurate data or, in a worst-case scenario, consent that isn’t truly informed.
Even with informed consent documents written in their preferred language, many patients don’t fully comprehend what they’re reading. 58.1% of participants show an intermediate understanding of informed consent documents, and 27.6% show a low understanding.
Now imagine if that document was written in a participant’s second or third language. This is why translations are so important for domestic and international trials.
For more information on patient-centric clinical trials, see these resources:
Turning Clinical Trial Translations Into a Reality
Clinical trial sites can make use of in-person interpreters or virtual interpreters available via video calls and apps. But it’s also important to ensure patient-facing documents or technology programs are translated.
There are dozens of documents that might need to be translated for participants in a clinical trial, including but not limited to:
- IRB-approved informed consent forms
- Patient diaries
- Quality-of-life scales
- Patient-Reported Outcomes (PRO)
If any of these documents are transmitted electronically, the user interface (UI) of the patient-facing application will also need to be translated. The UI includes all of the instructions, buttons, and sign-in and sign-out pages patients might see.
The Challenges of Translations
The process of translating clinical trial documents and software is complicated. Automated translations might be accurate enough for ePRO software, patient diaries, scales and questionnaires. However, automated translations probably aren’t accurate enough for informed consent documents.
This is why it’s important to look for consent software that:
- Has a translated interface
- Has the option for research sites to upload professionally translated documents
A user interface can easily be translated. But the research site and the IRB needs control over who translates critical documents, like informed consent forms.
How eConsent Can Empower Informed Consent Translations
Because informed consent documents are so important, it’s vital for sites and sponsors to ensure their eConsent software allows translated documents and has a translated interface.
Sponsors and coordinating centers are typically responsible for translating informed consent documents, often in collaboration with a medical translation company. But technology vendors need to assume responsibility for translating their user interfaces.
When searching for an eConsent product, ask whether the product has:
- A translated user interface
- Translated email communications
- A verification certificate from a medical translations company
- The ability for regulatory staff to upload translated documents
- The option for participants to change their language at will
- Translations for Legally Authorized Representatives and parents/guardians
- The capacity for interpreters to log in and sign documents as an additional signer
If you have specific questions about Florence’s eConsent features, you can view our eConsent product tour.
Bringing More Patients into Studies with Clinical Trial Translations
The number of Americans that speak a language other than English at home keeps growing. And although the U.S. remains the most common location for clinical trials, the number of international clinical trials and clinical trials hosted by other nations also continues to grow.
This means that investigators and sponsors can no longer afford to have 19% of trials require English proficiency–and we certainly can’t afford to not specify whether translations are available for 78% of trials.
Reliable translations and interpretation services need to become a commonplace and essential part of clinical trials. To make this a reality, clinical trial vendors must ensure their patient-facing technology offers translated interfaces and communication.
Florence eConsent will add more translations to our interface and email communications throughout 2022 and 2023. If you have questions about the process or when specific languages will be available, please contact firstname.lastname@example.org. You can also learn more about eConsent by taking our free, virtual product tour.
By Taylor Davidson, Content Writer
With contributions by Jovana Jakovljević, eConsent Translations Project Manager