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International Clinical Trials

Benefiting from Back Translations

Language plays a critical role in clinical research. Trial sponsors, medical ethical committees, investigators, research nurses, patients and healthy volunteers all need to be informed about the ins and outs of the trial, and eventually the results of the research project must be published. Furthermore, all this must be set out in clear, unambiguous language. During clinical trials a range of different documents are used. Many clinical trials cross national boundaries, and therefore must be multilingual in design.

The list of languages is no longer restricted to the ‘easy’ languages of the EU. These are still around, of course – and they now include many Eastern European languages – but trials are now run in other territories and these days trials often include study centres in Africa, Asia and Latin America. The advantages are clear: large numbers of treatment-naïve patients are keen to get involved. One stumbling block is the question of language. In some countries, it is not uncommon for people to speak one of possibly dozens of different languages or dialects. Many cannot read or write, making conventional informed consent forms (ICFs) impossible to fill in. How can you make sure that a question in a questionnaire means the same in Zulu as it does in Urdu? And are questions about ‘minor discomforts’ answered differently in a rich Western country than in an area that was a war-zone a few years ago?

The issues around language (problems as well as opportunities) are generally poorly understood. Language is often not considered to be an issue – it is simply taken for granted – until something goes wrong: for example, because there is an error in one of the language versions of the ICF and participants have consented to something they were not correctly informed about, or certain questions in a questionnaire can’t be used because the answers are not comparable across the different languages. Maybe language is not regarded as a primary concern because, when compared with the total cost of setting up and running a clinical trial, the language-related costs are relatively small.

DOCUMENTS INVOLVED IN CLINICAL RESEARCH

The study protocol describes the background and purpose of the clinical trial, the possible outcomes, the profile and recruitment of patients, insurance issues, and so on. The ICF is another important document in clinical trials. Its purpose is to inform participants in the study – usually the patient suffering from a certain disease or condition. Under the Declaration of Helsinki – an initiative launched by the World Medical Association in 1964 (and since then updated frequently) – participants must completely understand the information provided, including the risks associated with using the study medication or treatment.

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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 setup 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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Simon Andriesen
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