Clinical trials are where science and the real world meet face to face. They are a crucial step in the development of any new drug or therapy, and they necessarily take place at a crossroads not just between languages and cultures, but between the scientific community and ordinary people from all walks of life.
This means that translation and localisation play a huge role in facilitating communication and making these trials possible. It also means that huge demands are placed on the quality of this translation work. After all, miscommunications could literally set back the advancement of health and prosperity on our planet.
So for today’s edition of the blog, we would like to take a closer look at the fascinating area of clinical trial localisation. We will look at some key considerations and the extra steps that are normally included to ensure accuracy and quality in the translation of trial materials.
What Is a Clinical Trial?
A clinical trial is when a new treatment – whether it be a vaccine, a medication, a supplement, a medical device or something else entirely – is tested on humans. The aim is to study any behavioural or biomedical changes in the trial participants and ultimately to bring the product one step closer towards approval.
Clinical trials can vary generally in scope and size but typically they are divided into four different phases. It can take as long as a decade for a drug or therapy to make it through all four phases.
Often trials are focused on what are known as PROs or patient-reported outcomes. This is where patients report their own experiences of a drug or therapy by completing a questionnaire or an assessment form.
Clinical trials can be centred at one single institution or they might be multi-centre, spread across many different institutions and even countries. Increasingly, global trials can also be conducted virtually as so-called decentralised trials, which means they are less bound to a single location or language.
When Do Clinical Trials Require Translation?
Translations are often required to aid clinical trials for a number of different reasons. In the case of multi-centre studies or decentralised trials, for example, the scientists working on a trial may speak different languages and require assistance creating documentation in a common language.
In other cases, a clinical trial might be focused on a particular region of the world. Think Zika or Ebola, for example. These were outbreaks that occurred in localised parts of the world where various different languages were spoken – Spanish, French, Portuguese but also many indigenous and minority languages.
In such cases, translation is needed in order for researchers to communicate with each other, but it is also essential in allowing scientists and study volunteers to interact and exchange information. This is especially the case in urban settings where multiple languages are spoken and where proficiency may vary across different languages.
Why Not Just a Straight, Word-for-Word Translation?
Clinical trials are expensive and translation may seem like one area where costs could be cut. But there are many reasons why clinical-trial texts are almost always localised professionally rather than simply translated by a lay person or run through a machine-translation programme.
Perhaps the most obvious is the need for precision. Questionnaires completed by study participants usually ask very precise questions and any vagueness or ambiguity in the questions may be reflected back in the answers given.
If it seems as if respondents in one language have interpreted a question differently to respondents in another, this may invalidate the entire trial. Linguists therefore need to consider exactly how different readers may interpret certain words and pick their translation accordingly.
Another reason is cultural sensibilities and stigmas relating to how we perceive ourselves and others. Words that are neutral in one context or language may feel loaded or negatively charged in another. Consider synonyms like lazy, inert, sluggish, lackadaisical or bone idle. These all have similar meanings but may be interpreted or perceived differently. Some may feel insulting while others may feel more neutral but still have different associations that make them less suitable.
What is Full Linguistic Validation?
You may also have heard the term full linguistic validation in reference to clinical trials. This is an additional step in the translation and localisation process that has been recognised as best practices when translating PROs and similar documents to be used by study volunteers. Essentially, the idea here is to make sure that the final translation matches the original as closely as possible in meaning while also being adequately adapted to the target.
One component of this is back translation whereby the translation produced is then translated back into the source language by another linguist who has not seen the original text. This back translation is then compared against the original text so that any potential discrepancies can be caught and remedied by the team who produced the original translation.
This can then be supplemented by a clinician review or through a process known as cognitive debriefing. This involves testing the translated questionnaire or assessment with a group of people from the target language to ensure that they would understand its questions in the same way as the original. Again, any discrepancies can be logged and used to inform further editing of the translation.
Years of Experience with Clinical Trial Localisation
Here at Comunica, we have plenty of experience working with the translation and localisation of clinical trials. We understand the process and the importance of both accuracy and adaptation within this field, and we can work with you to incorporate full linguistic validation into the translation and localisation process if desired.
If you would like to learn more about how we could help you with your translation and localisation needs within clinical trials and PROs, please do not hesitate to get in touch for a no-obligation consultation or quote.
