Translation is essential for preserving and improving public health by facilitating the exchange of medical knowledge and information between languages. Translation ensured correct and fast information flow across borders and supported researchers' dissemination of therapeutic and vaccine development discoveries (Leonardi, 2022). Drug developers have the potential to bring new therapies by making new discoveries that meet major medical needs. Academic researchers face challenges in drug development and regulatory submissions to integrate academic findings in clinical practice (Kallio et al., 2023).
The foundation for the discovery of new therapeutics depends on developments in research. The process of translation is a process of presenting lab findings and clinical data and evaluating community observations into treatments that benefit individuals and public health. The basic layout of the process is shown in Figure 1. The spectrum that actually exists, however, conceals the complex, multi-stakeholder, continuous, and diverse research and development processes (Lalu et al., 2020).
Figure 1. Research spectrum of medical translation (Lalu et al., 2020)
Accurate translation helps promote effective communication among different stakeholders.
● All the data collected from clinical trials are accurately interpreted.
● Requirements of the different agencies are efficiently fulfilled by regulatory submissions.
● Ensuring patient safety and informed consent is a key to effective medical translation.
● All the relevant instructions and labels are in compliance with the local laws.
Lack of translatability results in a risk that preclinical data will not be relevant to clinical outcomes, making drug introduction to the market more challenging.
Translational research can fail due to several factors. Inadequate understanding of the medical translation process, improper data integration from different means to disease, use of models, and personal privacy when conducting human research can all contribute to challenges. These barriers significantly hinder translational science advancement. Following are some of the translational challenges associated with delayed development of new interventions (Ismayilli, 2024).
Terminology Issues
One of the most important requirements for effective communication in both monolingual and multilingual healthcare communities is the proper use of medical language. Medical terminology varies not simply because of language differences but also due to the different ways of communication among groups of people.
Eponyms: Diseases, methods, and discoveries named after people, such as "Down syndrome," possess special obstacles. Medical translators must evaluate the situation to make this information easy to understand.
Antonyms: Two different conditions are named by the terms, such as "benign" and "malignant," although they are often considered as cancer or tumor. To avoid misunderstanding, translators must explain these terms clearly and properly.
Synonyms: Many terms used in the medical sciences are similar. For example, the word "cardia" can be used for both the heart and the stomach's entrance. To avoid confusion, translators must identify the correct use of these terms based on the context.
Data collected from clinical studies is very large in volume, and for accurate regulatory submission, it must be translated properly. Any kind of missing or inaccurate data can result in rejections and failures. Inaccuracies in translated paperwork can cause
● Prolonged trial approvals
● Longer study timelines.
● Re-translation and submission parameters.
Patient instructions and drug package inserts must strike a balance between technical correctness and accessibility. Translators must alter these writings to match the comprehension levels of various audiences, including non-specialist readers. The use of plain language and clarity is the main aspect for the target audiences. Trained medical translators can improve understanding of the content by creating visual aids and complying with international guidelines. Incorrect understanding can cause patient harm or regulatory concerns.
Medical translation quality can have an impact on clinical processes; hence, verification is an important consideration. In the pre-translation phase, a valid verification process begins to check for readable content and clarity. Translation companies that follow European Standard ISO 17100:2015 ensure quality in different areas, such as evaluation of medical translators, proofreaders, and procedures of pre-production and post-production (Montalt et al., 2018).
For the past few decades, a great response has been seen from the layperson community in the western world who want to understand information about their health. The patient-centered concept is very important in the current healthcare setting. Claiming that patients are empowered in today's healthcare is impossible if they do not understand the information given to them (Montalt et al., 2018).
Translation is a critical factor in the story of drug discovery, influencing whether years of effort result in success or failure. If results from biochemical assessments, in vitro studies, in vivo evaluations, and, finally, clinical observations are consistent throughout this long story, then translatability is genuinely determined. However, a lack of resources like funding, infrastructure, policies, untrained staff, and support from organizations results in failure at an early stage, thus hindering the process of drug development. To address rising drug development costs, high attrition rates, and funding difficulties within the public research sector, industry and public research groups are exploring a joint collaboration model to reduce duplication of efforts (Seyhan, 2019). By addressing these problems with a combination of technical expertise, subject-matter knowledge, and cultural awareness, translators may improve the quality and efficacy of medical translations, securing their critical role in healthcare communication worldwide.
Figure 2. Phases of translational research and its challenges (Seyhan, 2019)
Patient Safety At Risk
For instance, the pharmaceutical phrase "take once daily" was wrongly translated into other languages as "take once." The patient would take only one dose of medicine rather than a once-daily dose of this medicine. It shows the importance of every single word for accurate translation (Ismayilli, 2024).
Financial Burden
To avoid any rejection, clinical trial reports, drug documentation, and pharmaceutical labels must comply with the regulatory requirements. Inaccurate information can result in a prolonged stay of the drug in development, thus leading to increased cost, wasted time and resources, and repeating all the procedures.
Ways To Overcome Challenges In Medical Translation
There are various complexities associated with the medical text translation. The following are effective solutions for addressing these difficulties (Ismayilli, 2024).
Using Clearly Defined Terms
For confusing terminologies like synonyms, homonyms, and antonyms, translators need to follow clear standards for effective translation. There should be proper guidelines for the evaluation of content and the use of detailed notes.
Efficiency and consistency can be achieved by the use of elaborative dictionaries and translation memory software. These tools will help translators to use uniform vocabulary and ensure compliance with approved medical practices.
Translators should stay in contact with medical experts, such as doctors, pharmacists, and researchers, to learn about the details of regulatory submissions and medical translation. Training workshops and continuous interaction among these groups can help overcome communication gaps.
As new practices and developments are increasing rapidly in the medical field, medical translators should have a motivation for learning by participating in training sessions and staying up to date with the most recent developments in healthcare. This continuing education will help translators to remain competent in their work.
In current healthcare settings, understanding of the leaflet information is emphasized for the patients. The Skopos theory ensured that the translated material was appropriate for the target audience's literacy level. Complexities of the medical terms can be reduced by adding descriptive notes to make the content more readable while retaining the meaning of the original concept.
In drug development, two major shortcomings are a lack of regulatory knowledge and a communication gap between regulatory persons and researchers. Academic researchers must have a sound knowledge regarding regulatory challenges for a strong regulatory framework. Various guidelines have been developed by national competent authorities (NCAs), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the International Conference on Harmonization to comply with current regulatory requirements in researchers product development plans (Kallio et al., 2023).
Implementing a peer review system in the translation procedure may significantly enhance quality. WillingJet LifeSciences is a trusted partner for medical translation services where your translations can be evaluated by other qualified translators or subject matter experts to identify and rectify potential problems before publishing. With this cooperative approach, medical texts are guaranteed to be more reliable and precise.
In the healthcare system, the translation of medical literature plays a very important role in patient safety, clinical efficacy, and the communication of medical information. One of the factors that create hurdles in the development of new interventions or cause them to fail completely is miscommunication and misalignment of priorities among scientific, medical, and patient disciplines that make up the translational team. Translators can bring new drugs to the market faster by employing strategies such as creating glossaries, using translation memory tools, and setting clear standards for challenging terms. Peer review processes and collaborative efforts with medical specialists ensure that translations meet the finest levels of precision and accuracy. The multidisciplinary team involved in drug development and translation is responsible for the reliability of the methods used, given the millions of dollars, thousands of hours, and significant amount of energy that are invested in the discovery of new drugs and, most importantly, the risks that humans are being treated with. When this point is reached, improved translatability reduces dropout rates and accelerates the drug discovery process.
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
Kallio, M. J., Starokozhko, V., Agricola, E., Burggraf, M., Heß, A., Ballensiefen, W., Löbker, W., Nuevo, Y., Pasmooij, A. M. G., & Mol, P. G. M. (2023). Translating academic drug discovery into clinical development: A survey of the awareness of regulatory support and requirements among stakeholders in europe. Clinical Pharmacology & Therapeutics, 113(2), 349–359. https://doi.org/10.1002/cpt.2789
Lalu, M. M., Montroy, J., Begley, C. G., Bubela, T., Hunniford, V., Ripsman, D., Wesch, N., Kimmelman, J., Macleod, M., Moher, D., Tieu, A., Sikora, L., & Fergusson, D. A. (2020). Identifying and understanding factors that affect the translation of therapies from the laboratory to patients: A study protocol. F1000Research, 9, 485. https://doi.org/10.12688/f1000research.23663.2
Leonardi, L. (2022). The importance of accurate medical translation in the context of the COVID-19 pandemic. 7, 1–13.
Montalt, V., Zethsen, K. K., & Karwacka, W. (2018). La traducció mèdica al segle XXI - reptes i tendències. MonTI. Monographs in Translation and Interpreting, 10, 9–25. https://doi.org/10.6035/MonTI.2018.10.1
Seyhan, A. A. (2019). Lost in translation: The valley of death across preclinical and clinical divide – identification of problems and overcoming obstacles. Translational Medicine Communications, 4(1), 18. https://doi.org/10.1186/s41231-019-0050-7
31 03 2025
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