As we started to explore in our latest Clinical Trial Corner post, multilingual clinical trial translations are an essential instrument enabling recruitment of racially and ethnically diverse populations as recommended by the US Food and Drug Administration (FDA) in its recent guidance for clinical trials. Importantly, multilingual components of clinical trials are critical not only for inclusion of subjects outside of the US, but also for inclusion of minorities living in the US. With these diversity and inclusion goals in mind, how can industry sponsors improve language access in medical product clinical trials? From informed consent form translations to social media translations for patient recruitment campaigns, how-to guides in the form of e-Learning materials, linguistic validations, and even localization and medical translation of patient questionnaires, these tools play a vital role in ensuring patient comprehension and participation of diverse populations in clinical trials.
Americans Are Multilingual, Even If Clinical Trials Are Not
As mentioned earlier, multilingual clinical trial translations are essential to diversity not only on a global scale, but also for the 23.5% of clinical trials worldwide that are conducted in the US. Even more strikingly, 32.3% of global industry Clinical Trial sites in 2021 were located in the US, nearly six times that of the next leading market. Yet despite 1 in 5 Americans speaking a language other than English at home, with rates even higher in states like California and Texas where many studies are based, few Clinical Trials are multilingual, instead requiring English-speaking participants. In fact, a recent study demonstrated that only 2.7% of studies registered on ClinicalTrials.gov mentioned accommodating participants who speak other languages.
What racial and ethnic populations could most benefit from multilingual clinical trial translations? As many are aware, over 40 million individuals in the US speak Spanish, a number that continues to grow. Hispanic/Latinx populations may be at higher risk for diseases like Alzheimer’s, providing unique opportunities for sponsors to target clinical trials to these participants using multilingual approaches.
But the opportunity for clinical trial translation is not just limited to Spanish speakers – millions of Americans speak other languages at home. Among Asian Americans, native speakers of Chinese (3.4M), Tagalog/Filipino (1.7M), Vietnamese (1.5M), Korean (1.1M) remain underrepresented in Clinical Trials, often because of limited language access. And other ethnic groups, such as French-speaking (1.2M) Haitians, are similarly underrepresented, often due to medical mistrust, despite substantial communities in American cities like New York, Boston, and Miami. Investing to expand recruitment, enrollment, and retention of these diverse patient populations through patient-centric communications is essential for sponsors to conduct high-quality medical research.
Engage Underrepresented Populations with Recruitment Material Translations
Streamlined localization of recruitment materials ensures consistency and cultural appropriateness of participant outreach within regulatory requirements. Translating patient portals and apps, clinical trial websites, and social media ads into participants’ native languages enable sponsors to engage with diverse populations more personally, with the goal of meeting recruitment targets quicker.
Conduct Multilingual Clinical Trials Efficiently with Informed Consent Form Translations
With cultural nuances that vary across ethnic groups, understanding local communities even within the US is critical to ensure the success of the participant-facing clinical trial materials used in enrollment and throughout study data collection. Informed Consent Form translations, linguistic validations, and localization of participant communications and Patient Diaries all benefit from subject-matter expert linguists able to ensure translation accuracy and linguistic validity, as well as quality controls for regulatory compliance like document formatting after translation. Building the trust necessary to engage underrepresented populations in clinical research requires this close level of attention to detail.
Retain Trial Participants Through eLearning Translations for Administrators
To enable effective communication between clinical trial sponsors and trial participants, clinical trial translations can provide significant aid at every stage of clinical trials. Taking advantage of clear communication strategies outlined by written and audiovisual eLearning training material localization to native languages, community recruiters are better equipped to explain clinical trial procedures to would-be participants. Translation of administrator materials, including e-Learning, not only model successful recruitment of study subjects, but also improves participants’ compliance and helps prevent misunderstandings that get in the way of successful trial completion.
Key Takeaways for Multilingual Clinical Trial Translations
Early awareness and focus by clinical trial sponsors on the linguistic enablement of multiracial and multiethnic population inclusion will improve recruitment, enrollment, and retention in line with the recent US FDA guidance, shortening clinical trials timelines and ensuring data acceptability by U.S. and international regulators. CSOFT Health Sciences, leaders in medical translations, provides a full range of translations for clinical trials in 250+ languages, including Spanish, Mandarin, French, and Tagalog, and can work with sponsors to best adapt clinical trials for diverse populations. Learn more about our multilingual clinical trial translation services at lifesciences.csoftintl.com.