Breaking Down Language Barriers

In clinical trials, every patient deserves a voice. Yet worldwide, countless patients miss life-changing opportunities simply because clinical trial localization—the process of adapting trials for different languages and cultures—takes far too long.

During a recent industry presentation, YPrime’s Jonathan Norman, Director of Localization, shared a stark reality: in a typical 10-country study, English-speaking populations may represent just 10-20% of potential participants. When study timelines get tight, underrepresented languages—particularly those from regions like India and Africa—are typically the first cut from scope. This creates a systematic barrier to diverse patient representation in clinical research, particularly for immigrant or diaspora communities in trial hotspots such as the US and Europe.

Take a listen here:

Innovation and quality are at the core of everything we do as an industry to improve clinical trials. That’s why every year, we participate in the Innovation Network Gathering—a forum for brilliant minds from various backgrounds to come together to engage in thought-provoking discourse that sparks new opportunities for growth and change.  

When we let localization challenges dictate clinical trial accessibility, we’re not just losing data points—we’re denying potentially life-changing opportunities to underrepresented groups of eligible participants. This isn’t just a translation vendor issue—success requires every stakeholder to reduce translation burdens on our trials, sites, and patients. 

Today’s clinical technology often lags behind consumer devices in clinical trial language support. While off-the-shelf smartphones can perfectly display a diverse range of languages and other writing systems, our industry still struggles with character corruption and display issues. The process remains highly manual: moving translated text between formats, importing it into systems, and conducting sentence-by-sentence reviews—a perfect use case for artificial intelligence (AI) in the localization process. 

Success requires three key stakeholders working together: 

1. Technology vendors must handle different alphabets and writing systems as seamlessly as consumer devices. If patients in countries like India can buy technology that displays their languages perfectly, why does our industry still struggle? Technology vendors are uniquely positioned to innovate the importing of translated text into their proprietary systems, particularly with the support of AI. Ensuring this is done accurately and efficiently reduces timelines for later steps of the process. 
2. Sponsors should proactively translate their content into new languages they need, particularly questionnaires they create themselves or use regularly across their studies. This creates a ready library of translations, investing in the future success of trials when engaging with more diverse language populations. 
3. Translation vendors need to modernize their approach. The original linguistic validation methodology we still use today was written before the smartphone era. It’s time to start innovating this process by making the most of technological advancements while maintaining the rigorous standards our industry demands. 

Looking Ahead 

The ISPOR guidelines that govern linguistic validation of patient-reported outcomes (PROs) turn 20 years old in March 2025. While these guidelines are reviewed and updated periodically, our industry shouldn’t wait to innovate. At YPrime, we’re exploring new ways to streamline the localization process with AI at the forefront through YPrime Labs, working to ensure clinical trial localization is no longer a rate-limiting factor in the life-changing work we do. Remember: while AI-powered translation might be the first application that comes to mind, our industry’s localization processes extend far beyond creating target language content. There are numerous opportunities to leverage AI across the workflow without compromising data collection integrity. We owe it to our patients to explore and implement these innovations thoughtfully. 

The path to more inclusive clinical trials starts with better localization. The technology exists. The need is clear. Now it’s time for action. 

The question for everyone in clinical research remains: what are you doing to ensure every patient has a voice? 

At YPrime, localization is integral to our electronic clinical outcome assessment (eCOA) offering. Localization in eCOA is essential for ensuring patient comprehension and accurate data collection across global clinical trials. When eCOA materials are properly localized, they go beyond simple translation by adapting cultural nuances, idiomatic expressions, and regional preferences to resonate with the patient’s native language and cultural context. This approach minimizes misinterpretation, reduces patient burden, and ensures that responses truly reflect the intended clinical outcomes. Effective localization supports regulatory compliance, enhances patient engagement, and ultimately contributes to higher-quality data, enabling sponsors to make better-informed decisions in diverse patient populations.