Top Five Translation Pitfalls in Multinational Clinical Trials

Top Five Translation Pitfalls in Multinational Clinical Trials

The most thorough method of evaluating how new treatments line up against current ones for a particular result is through clinical trials. Clinical trials should be planned and carried out to accomplish this goal since they have the potential to significantly affect patient care. Making sure that trial results are pertinent, suitable, and significant to patients in actual clinical settings is one method to do this. But only a small percentage of trials actually improve patient care, frequently as a result of the selection, gathering, and reporting of trial results. According to the World Health Organization (WHO), "choosing the most significant outcome is essential to establishing an effective recommendation." One of the top three goals for methods research, according to a study of 48 clinical trial centers in the United Kingdom, is "choosing acceptable outcomes to evaluate" (Heneghan et al., 2017).

Role of medical Translation in clinical trials

Nowadays, clinical trials are almost never limited to a single region. Multinational clinical trials are now the gold standard for guaranteeing varied participant representation and obtaining regulatory clearances across several markets due to the growing globalization of pharmaceutical research. However, one of the most important yet neglected issues that comes with this expansion is medical translation.

Willingjet Life Sciences, a pioneer in medical translation services, can help with this. Their proficiency guarantees the accurate, sensitive, and compliant translation of intricate medical documentation, enabling international clinical trials to proceed without unnecessary complications.The remainder of this article will discuss the Top 5 Translation Pitfalls in Multinational Clinical Trials and demonstrate how Willingjet Life Sciences assists research teams and sponsors in avoiding these potential risks.

Figure 1. Barriers in Translational Research (Fernandez-Moure, 2016) 

1. Misinterpretation of Medical Terminology

Abbreviations and phrases that vary in meaning based on the context are common in medical terminology, which is complex. Informed consent forms (ICFs) and clinical trial protocols may contain mistranslated terms that could lead to misunderstandings, poor communication, or even safety hazards.Two different conditions are named by the terms, such as "benign" and "malignant," although they are often considered as cancer or tumors. To avoid misunderstanding, translators must explain these terms clearly and properly (Montalt et al., 2018).

Willingjet’s Approach:

●       Hires linguists who are natural speakers of the target languages and have medical experience.

●       Makes use of databases and standardized medical glossaries to guarantee accuracy.

●        Uses a thorough quality assurance procedure with several review levels.

●       In every clinical setting, this methodical approach guarantees that language is both technically and medically precise.

2. Neglecting Linguistic and Cultural Variations

Culture and language are closely related, so what is acceptable in one nation may be strange or even offending in another.When creating patient-facing papers for clinical trials, such informed consent forms, patient documents, or recruitment materials, this is particularly important.Variations in language can lead to differences in how research questions are phrased.

For example, based on a study of family dynamics, how does family influence adult behavior? In a collectivist culture as opposed to an individualistic one, how can people contribute to family harmony? In this case, the focus on disparities reflects the different cultural values and interests of the societies (Ejjebli, 2024).

 Figure  2. Tools to enhance co-design in studies involving culturally and linguistically diverse (CALD) communities (Watson et al., 2025)

Willingjet’s Solution:

●       Employs cultural adaptation techniques to guarantee translations that are both patient-friendly and culturally aware.

●       In order to verify translations against local standards, the team works with reviewers who are in the country.

●       Aims to ensure that translations are appropriate for the patient's literacy level.

●       Researchers should refrain from oversimplifying or making generalizations in order to analyze various groups in a respectful and comprehensive manner.

3. Failure to Adhere to Regulatory Standards

Among the industries with the strict regulations in the world is pharmaceuticals. The regulatory agency makes sure that a drug complies with all applicable laws and regulations.Each nation has a regulatory body that is in charge of enforcing laws and regulations and issuing guidelines to control the production, marketing, licensing, registration, and labeling of pharmaceutical products as well as the drug discovery process. Clinical trials are subject to strict regulations in every nation. Regulatory agencies for translated materials include the FDA (U.S.), EMA (Europe), PMDA (Japan), and NMPA (China). Underestimating the level of accuracy required for translations to receive regulatory approval is a common mistake. A rejected submission, expensive delays, or additional work could arise from a poorly translated adverse event description or dose instruction (Rajeswari Kamisetti & Gupta Vankadari, 2019).

Expertise of Willingjet

●       Maintains a staff of professionals knowledgeable about international regulatory frameworks.

●       Updates in accordance with changing regional submission requirements.

●       Offers official regulatory-compliant certified translations.

●       Willingjet saves sponsors money, effort, and reputational risk by making sure documentation adheres to regulations from the beginning.

4. Ignoring Patient Levels of Comprehension

Patients do not understand medical language, but clinical trial workers do. Translating documents at a very technical level can be a major mistake that leaves patients unsure of what they are consenting to or how to follow trial procedures. A layperson might find pharmacokinetics too complicated to understand, while content that is too simplified could lose its accuracy (Ismayilli, 2024).

The patient-centric focus of Willingjet

●       Willingjet tests the readability of translated information to make sure the typical patient can understand it.

●       The content is both accurate and clear by maintaining a balance between medical precision and straightforward language.

●       Back-translations are provided to ensure that patient documents maintain their intent and meaning.

●       By lowering rates of withdrawal and building trust, this patient-centered approach helps in maintaining trial participant integrity.

5. Inconsistency Among Trial Sites

Consistency is crucial in international trials. However, when translations are poorly coordinated or handled by multiple sources, inconsistencies show up. This could result in several countries using different versions of case report forms or informed consent documents, compromising the comparability and validity of the data.

Figure 3. Inclusive Study Design Resources by Country (Watson et al., 2025)

Willingjet’s Integrated Process

●       Centrally manages the translation of all trial papers. Utilizes translation memory (TM) techniques to ensure uniformity among phases and sites.

●       Minimizes mistakes and misunderstandings by guaranteeing consistent updates upon document revision.

●       Willingjet guarantees that all participants, regardless of location, receive the same degree of precision and clarity thanks to this integrated approach.

The Reasons Willingjet Life Sciences Is the Best Partner

Selecting the correct translation partner is crucial in a field where a single mistranslation may ruin years of effort. What makes Willingjet Life Sciences unique is its

Life Sciences Expertise: Willingjet guarantees specialized knowledge by concentrating exclusively on pharmaceuticals, biotechnology, and healthcare, in contrast to typical translation companies.

Professional Medical Translators: Every translator has medical training and speaks the source and target languages with proficiency.

Comprehensive Clinical Trial Support: Willingjet handles every aspect of trial documentation, from protocols and investigator guides to informed consent forms and patient logs.

Technology-Driven Accuracy: AI-powered terminology management, smart translation memory tools, and safe platforms accelerate the procedure while ensuring privacy.

Dedication to Quality and Compliance: The highest standards are ensured by ISO-certified procedures.

Conclusion

Modern drug research relies heavily on multinational clinical trials, yet their success depends on cross-cultural and cross-linguistic communication. Misunderstood language, intolerance for cultural differences, non-compliance with regulations, inadequate patient understanding, and inconsistent documentation are the top 5 translation pitfalls that could compromise patient safety and trial integrity.

Sponsors and CROs that work with Willingjet Life Sciences get more than just a translation service; they get a reliable partner dedicated to patient comprehension, compliance, and clarity. Willingjet's unique knowledge facilitates the seamless cross-border conduct of clinical studies, promoting innovation and providing patients around the world with innovative treatments.

References

Ejjebli, S. (2024). Unlocking the power of language: Navigating linguistic diversity in cross-cultural research. Studies in Pragmatics and Discourse Analysis, 5(1), 46–62. https://doi.org/10.48185/spda.v5i1.1020

Fernandez-Moure, J. S. (2016). Lost in translation: The gap in scientific advancements and clinical application. Frontiers in Bioengineering and Biotechnology, 4. https://doi.org/10.3389/fbioe.2016.00043

Heneghan, C., Goldacre, B., & Mahtani, K. R. (2017). Why clinical trial outcomes fail to translate into benefits for patients. Trials, 18(1), 122. https://doi.org/10.1186/s13063-017-1870-2

Ismayilli, T. (2024). Navigating complexities in medical text translation: Challenges, strategies, and solutions. Acta Globalis Humanitatis et Linguarum, 1(2), 170–176. https://doi.org/10.69760/aghel.01024080

Montalt, V., Zethsen, K. K., & Karwacka, W. (2018). La traducció mèdica al segle XXI - reptes i tendències. MonTi Monografías de Traducción e Interpretación, 10, 9–25. https://doi.org/10.6035/MonTI.2018.10.1

Rajeswari Kamisetti, R., & Gupta Vankadari, R. M. (2019). Regulatory challenges in clinical trials: Strategies to overcome commonly observed deficiencies. Journal of Intellectual Property Rights 24(Sept-Nov):, 24, 140–148.

Watson, E., Gulline, H., Jane, S. M., Woollett, A., & Ayton, D. (2025). Improving participation of culturally and linguistically diverse participants in clinical trials: An expert consultation. Trials, 26(1), 105. https://doi.org/10.1186/s13063-025-08803-z