Challenges with translation of clinical trial data

Lots of fragmented pieces of data. Clinical trials consist of many documents such as consent forms, patient questionnaires, patient diaries, clinical study protocols, investigator brochures, phase IV documentation, clinical study reports, and others. A single project can have hundreds, if not thousands, of such documents. This then has to be translated to numerous languages in which the trial is to be done. Once the trial is done, the data have to be translated back into the source language. So, it’s not just lot of data, but data that lives in many documents.

As data is the content that needs to be translated, accuracy and relevance become a challenge. The content consists of forms, figures, diagrams, observations, and the like.

Time management. A clinical trial is typically conducted in several countries in parallel, which means that the data from all these trials ends up for translation at nearly the same time. What’s more, all of it has to be translated on priority and delivered to the R&D department at the company headquarters for them to analyze the results. The schedule is obviously very tight. So, the translation process needs to be one that has already been validated in terms of efficiency, quality of output, and speed.

Quality of the content. Patient data forms a big part of clinical trials. These forms are still often filled in by hand. They are then scanned and sent for recording and translation. The quality of these scans is often poor and the text is hardly legible. Yet, the translation must be error-free. Apart from this, the same form layout must be retained in the translation.

How to get clinical trial translation right

Working with a multilingual communications agency experienced in clinical trial translation is critical to assuring a smooth and efficient process. This is the only way you can be assured of quality, timely delivery, and the integrity of the translation. The agency will provide you with translators and reviewers who have experience in clinical trial translation. You can also fall back on its processes of quality assurance which have been arrived at painstakingly over time.

We list below three things that are important in getting clinical translation right. Your translation partner will take care of all of this, but a clear understanding of what’s involved is important for the client, too.

1. High-quality desktop publishing (DTP) makes a huge difference in clinical trial translation. There is no scope for errors in the document formatting, as it can lead to huge errors in data if the data in one field skips to the next field or something similar happens. The DTP professional needs to be conversant with the layout requirements of clinical trial reporting for different countries. The tools used, too, must be able to handle different document formats and possess multilingual capabilities. For languages with right-to-left or vertical orientations, the translation must be accurate as well as all the elements on the document must be placed appropriately.

2. Terminology needs to be localized for a good understanding of the requirements of a clinical trial. Remember that people can use different words to mean the same thing even when they are speaking the same language. This is because there are always variations in how people use the same language. It happens a lot with languages such as English, Spanish, French, or Arabic that are spoken in many countries in different social and linguistic contexts.

When translating from one language to another, it’s very important to use the right term in the target language. The intended audience, in this case, are people signing up for the trial must be able to relate to the term in the intended sense.

3. The use of computer-aided translation (CAT) software is important for four reasons:
(a) The CAT tool breaks up sentences into strings. This makes translation go faster and easier.
(b) the translated string is saved with the source string. This makes it easier to refer back to in the future.
(c) The translated strings are saved in a database called the translation memory. When the same sentence turns up for translation in the future, the tool will automatically show the previously translated sentence to the translator. The translator can simply go on to translate new text, thus saving precious time and money. There is also the added advantage of maintaining quality, which saves time on reviews as well.
(d) CAT tools also include a termbase, where all approved terms are saved. Translators can refer to it to understand how to use different terms, which ones should not be translated, and more.

Of course, remember that the tools are only as good as how you use them. So, the multilingual communication company must be adept at these tools and use them effectively.

Translation is a complex process and translation of clinical trial data, even more so. But when you work with the experts, you get to focus on your core tasks and not have to worry about the nitty-gritty.

Choose your translation partner wisely: translators will prove to be just as important as the researchers and medical professionals you work with. Errors in translation can cost a lot to correct, apart from the serious consequences it might cause.