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International Clinical Trials

Translation on Trial

 

Producing questionnaires for use in international, and therefore multilingual, clinical trials is a delicate and complex task. Apart from the language aspects, there are often cultural differences and certain concepts may not be translatable into all languages. This article discusses some of the most important translation guidelines, defined by different international organisations.

Patient-reported outcome (PRO) forms, such as questionnaires, are the most important documents in clinical trials. They are used to collect information from patients, either directly (by patients filling in the questionnaire) or through an investigator or interviewer who records the patient’s responses onto the form. PROs are most often used to collect information on quality of life (QoL) in general, health-related quality of life (HRQoL), disability, and physical or mental symptoms of disorders or conditions (for example, asthma, migraine and urinary incontinence). The information collected using PROs is fed into a database, which is then used for further research.

The original version of a PRO is usually the result of a joint effort by several researchers who spend a lot of time and energy in generating a high-quality instrument. The authors pay a lot of attention to the precise wording of the questions and – in case of multiple-choice – the answers. It is then heavily tested, both on understandability of the questions and on measurability of the outcomes. Producing a PRO is one thing; it is a complex matter requiring considerable skills across different disciplines.

Producing multiple language versions of a PRO is an even more complex matter; this is considered to be one of the most sensitive challenges for translators. It is never just translation; it is always translation plus adaptation to a specific region, or locale (this process is also referred to as ‘localisation’). During localisation, a variety of issues need to be taken into account and, while language is important, it is certainly not the only one. Other issues concern culture, literacy levels and the understanding of key concepts.


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Simon Andriesen is Managing Director of MediLingua BV, a company based in The Netherlands that is fully focused on translation, localisation and testing of pharmaceutical, clinical trial, biomedical and medical technology information. He has been involved in writing and translation for over 25 years. Simon is also a member of the Advisory Board of the Medical Translation Roundtable at Localization World, a series of high-level conferences about translation and localisation; he set up and coordinates a course on medical-pharmaceutical translation; and is a frequent speaker at conferences about language, medical translation, medical writing and readability testing.

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