A YPrime Blog By:
Jonathan Norman,
Director, Localization Services
Diversity and inclusion have become key concerns in clinical trials—and for good reason. Ensuring studies represent a wide range of populations is crucial for developing treatments that work for everyone. However, a hurdle in achieving this diversity is often minimized: language barriers. This is where the process of localization comes into play.
Understanding some foundational concepts is essential to grasping the importance of localization. At the core is eCOA (electronic Clinical Outcome Assessments)—the technology clinical trial staff and participants use to collect data. eCOA systems usually incorporate patient-facing questionnaires specifically developed to measure and document outcomes or symptoms experienced by trial participants. Frequently referred to as “instruments,” they are often designed for specific therapeutic areas or symptom categories, and many require special permissions for use through a process known as COA licensing. For global implementation, these tools need accurate translation into multiple languages. This is where localization comes in—the comprehensive process of ensuring that all elements of a clinical trial, including eCOA instruments, are accessible to stakeholders in a particular location through translation and a holistic adaptation to local contexts and needs.
The process of preparing eCOA instruments for global use can be time-intensive. When study timelines become constrained—as they always seem to do—translations for diaspora or minoritized languages are often among the first tasks to be cut. Sometimes, even entire countries are removed from studies rather than creating the translations required. By cutting corners on localization, many potential participants are effectively excluded.
The Vocabulary of Language
Diaspora language: A language spoken by a community that has migrated from their original homeland and is maintained by that community in a new geographic setting (e.g., Chinese in the US or Polish in the UK)
Addressing this challenge requires a collaborative effort from all stakeholders in the clinical trial ecosystem. Technology partners need to develop “localization-ready” systems from the outset. Artificial intelligence (AI) plays an increasingly important role in this, with tools being developed to automate many manual parts of the process, potentially reducing processing time significantly. Sponsors can proactively translate content for languages they might need in the future and play a greater role in translation reuse, where appropriate—something often expected of vendors but made difficult by uncontrolled content changes by the study team. Translation providers can innovate their processes to keep pace with technological and conceptual advancements while continuing to focus on ensuring accurate, culturally appropriate translations.
The ISPOR guidelines have served as the trusted standard for translating patient-reported outcomes (PROs) for nearly two decades. As AI and other technologies advance, stakeholders may want to consider enhancing these foundational guidelines to embrace new innovations while maintaining rigorous ISPOR standards.
A more inclusive approach to localization is key to enhancing diversity in clinical trials, and every stakeholder has a role to play in facilitating this process. Whether as a sponsor, translation provider, or technology partner, it’s crucial to consider how to ensure that every potential participant is given a voice regardless of their language or location. Diversity in clinical trials isn’t merely about meeting quotas; it’s about developing treatments that are effective for diverse populations worldwide. Breaking down language barriers is the first step in this journey toward better global health.
About the Author
With seven years of experience in localizing paper and electronic COAs, Jonathan Norman today leads translation and questionnaire licensing strategies for YPrime. He develops innovative approaches to ensure quality and accuracy in translated clinical trial materials, focusing on reducing translation burdens and increasing trial diversity. With a passion for language and culture, Jonathan is a linguist and translator who has spent a decade translating everything from media/TV advertisements to life sciences material. Upon joining the clinical research field, he quickly progressed from project manager to director roles in linguistic validation and quality assurance. He’s a trusted SME in localization best practices, maintaining strong relationships with eCOA providers, pharma sponsors, and copyright holders across the clinical research industry.
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