Anybody doing translation work related to clinical trials knows that so-called "back translations" are a fact of life - most drug companies rely on back translations as a QA tool by comparing the back translation and the source to one another.
However, any translation that is done well will depart from the semantics and structure of the original source language. Grammar is inherently diverse across different languages, and the translator will retain the meaning of the translation, rather than the original grammatical properties of the source text.
Not surprisingly then, there exists a healthy debate on the use and usefulness of back translations.
In our experience, the usefulness of back translations is highly dependent on the content that is being translated. In the context of informed consent forms, the consensus is that back translation should be performed to ensure that the language is a correct translation of the original, i.e., the meaning was not changed but also that the readability of the text has not been affected through the translation process. Additionally some Institutional Review Boards have made back translations a necessary step in the approval process.
For patient reported outcomes, back translations are a necessary part of the validation and cultural adaptation of the instrument for specific markets. The process includes conducting two back translations and harmonization with the original translation to accommodate the findings of the back translation.
Other content, for instance technical material or advertising and marketing material, may be better suited for an in-country review or an additional copy edit or adaptation step.
The bottom line? Use back translations with caution. It is not a silver bullet, and it can be a time-consuming and expensive task. But when employed correctly, back translations are a highly effective validation tool.
For more on the case for - and against - back translations, take a look at the following:
- Darren Clayson explains the intricate (and mandatory) process for back translations in Translation & Linguistic Validation of PRO Measures
- Back translations - tackling discrepancy in meaning highlights some of the linguistic challenges involved
- Our own Hilary Davies presented the terrific Best Practices for Back Translation as a QA Tool
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Categories: clinical research