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Medical and Pharma Clients: Are You Using the Right Translation Tool?

For medical and pharmaceutical clients, back translations are necessary facts of life; they are absolute requirements for most clinical research documents that must be translated into other languages.

But for experienced professional translators and editors who work in this area, back translations seem a wrongheaded way to approach accuracy and faithfulness to the source document.

Why would governmental agencies require a back translation of all clinical trial documents as a matter of course? In a cogently argued article in ICT (International Clinical Trials, summer, 2008, pp.16 ff.), Simon Andriesen points out that,

  1. everyone involved needs to be informed about all aspects of the trial,
  2. the results of the research will need to be published,
  3. documents must be written in clear, unambiguous language,
  4. many trials are performed across national boundaries, and
  5. consequently, the research must be multilingual in design for accurate comparative cross-country evaluation.

To accomplish this, factors that need to be considered include evaluation of the source questions as well as the target translation.

For example, when a patient in India or China is asked to evaluate the level of discomfort (from 1-10) of a procedure and rates it a 2 (slight discomfort) because they are accustomed to living with a certain level of pain, is that really comparable to a 2 given by a patient in France or Germany, someone who is not accustomed to living with pain?

The people engaged in design of the research need to ensure that answers are comparable across national and linguistic boundaries. How can the source language and translations of a question help accomplish this?

Translators and linguistic editors are not concerned with evaluating research design nor for comparability of results across linguistic boundaries. They are concerned with linguistic accuracy, naturalness, and proper form, which are really very different from the concerns of a medical researcher or government agency.

“It is usually the case that the linguistic aspects of a clinical trial are given short shrift, and not enough time and effort are spent on how translations and back translations can aid the research process …”

And for translators, their arguments against back translations are perfectly valid: a good translation, along with good editing, is much to be preferred as valid linguistic procedures over back translation. This is especially true if both the translation and back translation are rushed to meet a tight deadline, and the people evaluating the back translation do not really know what they should be looking for.

For example, if a back translator uses the word “brave,” but the original English had “courageous,” the client should not be focused on this as an error in translation: it’s not, the meaning is exactly the same.

Another example would be judging it a mistranslation if a back translation uses “participates in” for “takes part in.” Minor variations like these do not indicate translation errors, they simply reveal the many correct, possible choices in a language.

Rather than criticizing a back translation for changed word order or slight, seeming differences in word choice from the source, which translators understand is the correct way to go about conversion from one language to another, Andriesen argues that people who evaluate forward and back translations should be looking at comprehensiveness (inclusion of all points in the source document) and comparability across languages.

True, this demands a great deal of time and trouble, but it is the true rationale behind requiring back translations. It is usually the case that the linguistic aspects of a clinical trial are given short shrift, and not enough time and effort are spent on how translations and back translations can aid the research process, provided they are performed correctly.

Andriesen concludes his excellent article with: “If back translations are merely done to be kept on file or to satisfy ISO auditors, the efforts and cost are a total waste. When taken seriously and done in a professional way, a back translation effectively can identify the shortcomings of a translation – although one may argue whether it is cost-effective. A final edit stage, with a detailed commentary or a double forward translation, will probably provide the same level of confidence.”

EDITOR’S NOTE: Linguistic Systems has decades of experience serving life sciences, biotech, pharmaceutical, and medical firms. Trust us with your next translation project.