The importance of translation in clinical research

All new drugs and some medical devices must undergo rigorous, highly regulated clinical trials prior to their use in medical practice. While a few decades ago clinical trials were performed predominantly in their country of origin, nowadays there are increasingly more international studies (Figure 1). 

Figure 1 - Percentage of clinical trials by location (data from 20 December 2021, available at www.clinicaltrials.gov). Abbreviation “USA”: United States of America.

This internationalization comes with great advantages, such as improving the quality of results, since the patient sample is potentially larger and more representative of reality. However, it also entails major challenges, namely the complexity of regulations (often different from country to country) and multilingual communication between people native to these distinct languages and cultures.

Medical translation is a key component of multilingual communication and international clinical research.

All clinical trials require the preparation of various written documents, from informed consent documents with a description of all details of the study, to clinical protocols with the goals, methods and organization of the clinical trial, and patient-reported outcomes (PROs). For further details, see the articles on the role of translation in drug development and in PROs.

These are highly specialized and complex formal documents, since they involve the use of medical and technical terminology. The professionals who produce and translate these documents must be aware that patients have different degrees of comprehending their content. To facilitate an understanding of the trial, supplementary materials are often produced with various types of patient instructions, such as appendices and data collection forms.

From a practical standpoint, medical translation is essential in ensuring:

1. The safety of patients
   
   Properly translating the documentation required in a clinical trial is a critical step for it to be safe for patients. First, participants must properly understand what the study entails and decide whether they want to participate. Then, they must comprehend and properly follow the instructions. Otherwise, patients’ health may be compromised, resulting in suspected unexpected serious adverse reactions (SUSARs). 
    
2.  Approval of submission to regulatory authorities
    

   Each country has its own regulations for the sale and distribution of drugs. Anything out of line with local regulations may result in the delay of drug approval or having to entirely redo the clinical trial.

   In this case, not only is it important to ensure that all documents submitted to regulatory authorities have been properly translated, but also that they have been correctly adapted to the market and local culture. In other words, proper translation and localization of the language is critical.

3. Reputation and financial soundness of companies
   
   The reputation and financial results of a pharmaceutical company, medical device manufacturer or clinical research organization (CRO) may be impacted by mistranslations in documents needed for clinical trials. On the one hand, a concern for patient safety must be a priority; on the other, if the submission to the regulatory authorities is rejected, this may result in lost time and money for the company.

Although the consequences of an incorrect translation may be extremely serious for patient health, clinical trial credibility and company finance, the translation process is often the last step in planning an international clinical trial. In fact, it is rarely given the proper attention.

Never underestimate the importance of this process, and look for certified companies with professional translators to ensure that all documents are properly translated and adapted to the desired cultures.

L10N is a company specializing in medical and pharmaceutical translations, certified in standard ISO 17100 for 120 languages, with a team of professional translators with experience in the area of healthcare and native speakers of the required language. Medical and pharmaceutical companies can benefit from translation, revision, localization and linguistic validation services for:

• Informed consent documents for patients, clinical protocols and supplementary instructional documents for clinical trials;
• Packaging, labelling and instructions for use for drugs and medical devices;
• Declaration of conformity and technical file for obtaining CE certification for medical devices;
• Reports for notification to INFARMED, such as SUSAR (suspected unexpected serious adverse reaction) reports;
• Clinical outcome assessment (COA) reports, namely clinician-reported outcomes (CROs), laboratory-reported outcomes (LROs) and patient-reported outcomes (PROs).

References:

Locations of Recruiting Studies, ClinicalTrials.gov – NIH (U.S. National Library of Medicine), available at https://clinicaltrials.gov/ct2/resources/trends#LocationsOfRegisteredStudies, accessed in December 2021.

Medical Translation in Clinical Research, https://www.appliedclinicaltrialsonline.com/view/medical-translation-clinical-research, accessed in December 2021.

McKown, S. et al. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. Journal of Patient-Reported Outcomes, 2020.