Services | 24.09.2009

Translation of clinical trials documentation

Translation is a vital element of running a successful international clinical trial. Getting it right means quicker time to market, yet the complex process can create many stumbling blocks. This article highlights the key factors to consider, and how to choose the right translation partner.

Among the more wonderful creations of the science fiction writer Douglas Adams was the Babel Fish. This remarkable creature, when inserted into the ear, had the amazing ability to instantaneously translate any language the listener was hearing into their own native tongue. Although we may lack the wizardry of Adams’ creation, the challenge for translation in multinational clinical trials remains the same – to ensure unambiguous, culturally relevant communication to everyone involved in the process.

As well as meeting regulatory requirements, successful translation in clinical trials will also ensure that a client’s product gets to market more quickly. That is why it is imperative to start thinking about translation requirements – and specifically, who is going to do the work – as soon as possible in the trials process.

International clinical trials require a multitude of documents to be translated. Patient-facing communications are usually top of the list. These can include informed consent forms, patient-reported outcome forms, application forms and legal documentation on patient rights. Patient-reported outcome forms are particularly challenging, as they lie at the heart of the clinical trials process. Any ambiguity in the responses between patients in different countries risks invalidating the entire trial. Equally challenging are any patient communications aimed at children; these require specialist experience of translating for this group, in addition to language skills. Partners and legal bodies involved in the process also require translated documents. Correspondence between different countries’ research teams or hospitals, study guidelines, funding letters and insurance documentation are examples of this.

Effective translation is a critical requirement for a successful international clinical trial. Get it right, and you will not only improve the quality of your research, but you will also reduce the time to market for the drug by meeting strict regulatory requirements. Get it wrong and you risk costly delays to the trials process, to the detriment of both the manufacturer and the patient. Until Douglas Adams’ Babel Fish becomes a reality, the best way to achieve success is to plan your translation requirements well in advance, as an integral part of the process, and to be sure to choose the right partner.

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